Method for controlling flow of intestinal contents in a patient&#39;s intestines

ABSTRACT

There is provided a method for controlling a flow of intestinal contents in the intestinal passageway of a patient&#39;s intestines. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the intestinal tissue wall) at least one portion of the intestinal tissue wall to influence the flow in the intestinal passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the intestinal passageway. The method can be used for restricting or stopping the flow in the intestinal passageway, or for actively moving the fluid in the intestinal passageway, with a low risk of injuring the intestines.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/262,050, filed Sep. 12, 2016, which a continuation of U.S. patentapplication Ser. No. 14/228,578, filed March 28 and issued on Sep. 13,2016 as U.S. Pat. No. 9,439,745, which is a continuation of U.S. patentapplication Ser. No. 12/285,794, filed Oct. 14, 2008 and issued on Apr.15, 2014 as U.S. Pat. No. 8,696,543 which claims the benefit of U.S.Provisional Application No. 60/960,716, filed on Oct. 11, 2007, theentire contents of each of which are hereby incorporated by reference inthis application.

FIELD OF THE INVENTION

The present invention relates to controlling the flow of intestinalcontents in the intestininal passageway, and in particular, to a methodfor controlling the flow of intestinal contents of a patient sufferingfrom intestinal dysfunction intestinal passageway.

BACKGROUND OF THE INVENTION

There are diseases that prevent a patient from maintaining normalcontrol of the flow of intestinal contents in the patient's intestinalpassageway, such as anal incontinence, reduced peristaltic function ofthe intestines and constipation of the intestines. (The term “patient”generally includes human beings, but may also include animals.

Also, the term “intestines” generally includes small bowel, large bowel,and anus (anal channel including the anal sphincter). This means thatthe term “intestinal passageway” includes the entire passage from thestomach to and including the anal orifice.) In particular, analincontinence is a widespread disease and often occurs because of amalfunctioning of the anal sphincter, which causes an uncontrolleddrainage of fecal matter through the anusintestinal passageway.

Several kinds of sphincter plastic surgery are used today to remedy analincontinence, i.e disability to close the anal sphincter. There is aprior manually operated sphincter system in an initial clinical trialphase where a hydraulic sphincter system connected to an elasticreservoir (balloon) placed in the scrotum is developed. A disadvantageof this system is that thick, hard fibrosis is created around thereservoir by pump movements making the system useless sooner or later.Another disadvantage is that the use of hydraulic fluid always entails arisk of fluid leaking from the implanted hydraulic system.

Furthermore, it is a rather complicated task to manually pump thereservoir when defecation is needed. U.S. Pat. No. 5,593,443 discloseshydraulic anal sphincter under both reflex and voluntary control. Aninflatable artificial sphincter with the pump system in scrotum isdisclosed in U.S. Pat. No. 4,222,377.

U.S. Pat. No. 4,739,764 discloses a method for treating analincontinence by electric stimulation of nerves connected to musclescontrolling the anal sphincter. The function of the anal sphincter isaffected by applying electric pulse trains on the nerves. One generalprior solution to the problem of malfunctioning sphincters of a humanbody has been to implant an artificial sphincter that replaces amalfunctioning sphincter. A variety of artificial sphincters have beenused in the past. These artificial sphincters have included cuffs,clamping elements or inflatable bands that are applied externally aroundthe bodily organ that is connected to the malfunctioning sphincter.

For example, U.S. Pat. No. 6,074,341 discloses a mechanical device inthe form of a loop member that is applied around a patient's organ toreplace the missing or damaged sphincter. The loop member includes awire which is used to constrict the organ in question to close theintestinal passageway.

A disadvantage common to all prior artificial sphinters is that hardfibrosis may form around the artificial sphincter over time and maycause malfunction of the artificial sphincter. Thus, the formed fibrosismay sooner or later become a hard fibrotic layer which may make itdifficult for the artificial sphincter to work.

Another more serious disadvantage of the prior artificial sphincters ifused for replacing malfunctioning anal sphincters is that the element ofthe artificial sphincter that constricts, clamps or restricts theintestines may injure the tissue wall of the intestines. Thus, aconsequence of the element's constricting action on the intestines isthat the element might erode into the intestines over time, and in aworst case, penetrate the constricted wall portion of the intestines. Inaddition, blood circulation in the constricted tissue wall portion ofthe intestines is eventually hampered by the pressure exerted by theelement, so that poor blood circulation, or worse, no blood circulationresults in deterioration of the constricted tissue.

One solution to prevent tissue deterioration due to poor bloodcirculation could be to apply two or more separately operatingconstricting elements along respective tissue wall portions of theintestines and operate the elements sequentially, whereby each tissuewall portion would have time to recover, i.e., restore normal bloodcirculation while one of the other tissue wall portions is constricted.However, an apparatus devised in accordance with this solution wouldhave several disadvantages. First, the apparatus would require a largeamount of space, making it impractical to implant. Second, the operationof the apparatus in moving the constricting elements betweenconstricting and non-constricting positions day and night would requirea large power supply. Such a large power supply would necessitate theimplantation of a very large, high capacity battery and/or asophisticated system for continuous wireless transmission of energy fromoutside the patient's body for frequent charging of an implantedrechargeable battery. Thus, because of its large size and high powerconsumption, the apparatus would be impractical or even unrealistic.Third, a sophisticated control system would be necessary to control themoving elements. Finally, such a complicated apparatus of the typedescribed above would significantly add to the costs of treating amalfunctioning sphincter.

Another solution to the problem of malfunctioning sphincters that hasbeen previously used has been the electric stimulation of the sphincter,to restore its normal function, i.e., the contraction and closing of itsassociated intestinal passageway. This solution would work where thenormal sphincteric function is somewhat reduced and has not completelyceased. European patent application 1004330 A1 discloses an example ofsuch a solution, in which electric pulses are delivered to the loweresophageal sphincter of a patient suffering from reflux disease tominimize reflux. However, the esophageal sphincter has to becontinuously stimulated with electric pulses to keep it closed, exceptwhen the patient eats, which may result in a decreased stimulationeffect over time. An even more serious drawback to this solution is thatthe continuous stimulation over time might cause tissue deteriorationdue to poor blood circulationintestinal passageway.

The use of electric stimula to restore the sphincteric function of amalfunctioning anal sphincter is only possible if the anal sphincterresponds sufficiently to the stimula, i.e., closes the intestinalpassageway of the intestines. In cases where the sphincteric function ofan anal sphincter has completely ceased, or the anal sphincter has beenremoved from the patient's body, electric stimulation cannot beemployedintestinal passageway.

Electric stimulation of intestinal organs other than anal sphincters canonly insignificantly affect the flow of intestinal contents. Forexample, it is true that electric stimulation of the small intestine ofan anal incontinent patient affects flow of intestinal contents, butcould not possibly fully close the intestinal passageway, at least notby employing the necessary low stimulation intensities that are harmlessto the human body.

Intestine dysfunction may also involve disability of controlling themuscle that contracts the bowels, colon or rectum to providetransportation of the content thereof. Such a disability usually causesconstipation. In particular paralysed patients may suffer fromconstipation.

BRIEF SUMMARY OF THE INVENTION

The object of the present invention is to provide a method forcontrolling the flow of intestinal contents in the intestinal passagewayformed by the tissue walls of a patient's intestines, so as to at leastsubstantially or even completely eliminate the injured tissue wallproblems that have resulted from implanted prior art devices thatconstrict similar bodily organs.

In accordance with this object of the present invention, there isprovided a method for controlling the flow of intestinal contents in theintestinal passageway of a patient's intestines, the method comprising:

a) gently constricting a portion of the tissue wall of the intestines toinfluence the flow in the intestinal passageway, and

b) stimulating the constricted wall portion to cause contraction of thewall portion to further influence the flow in the intestinal passageway.

The present invention provides an advantageous combination of the methodsteps (a) and (b), which results in a two-stage influence on the flow ofintestinal contents in the intestinal passageway of a patient'sintestines. Thus, applying a relatively weak force against the wallportion gently constricts the tissue wall and the constricted wallportion is stimulated to achieve the desired final influence on the flowin the intestinal passageway. The phrase “gently constricts a portion ofthe tissue wall” is to be understood as constricting the wall portionwithout substantially hampering the blood circulation in the tissuewall.

Preferably, step (b) is performed by intermittently and individuallystimulating different areas of the wall portion. Such an intermittentand individual stimulation of different areas of the wall portion of theintestines allows tissue of the wall portion to maintain over timesubstantially normal blood circulation.

The method of the present invention can be practiced on any place on theintestines, which is a significant advance in the art, as compared withprior stimulation devices that are confined to electric stimulation ofmalfunctioning sphincters.

The constriction step (a) and stimulation step (b) may be performedindependently of each other or simultaneously. Optionally, step (b) mayor may not be performed while step (a) is performed.

Initially, the constriction of the wall portion can be calibrated bystimulating the wall portion while adjusting the constriction of thewall portion until the desired restriction of the flow in the intestinalpassageway is obtained.

Flow Restriction

It should be understood that any embodiment or part of embodimentdisclosed below in connection with flow restriction for the constrictionand stimulation devices combined in the constriction/stimulation unitcould be used for the separate constriction device and separatestimulation device, where applicable.

The method of the present invention is well suited for restricting theflow of intestinal contents in the intestinal passageway of a patient'sintestines. Thus, in a principal embodiment of the invention, the wallportion is constricted, so that the flow in the intestinal passageway atleast is restricted and the constricted wall portion is stimulated to atleast further restrict the flow in the intestinal passageway.Specifically, the wall portion is constricted to a constricted state, inwhich the blood circulation in the constricted wall portion issubstantially unrestricted and the flow in the intestinal passageway isat least restricted, and the constricted wall portion is stimulated whenit is in the constricted state to at least further restrict the flow inthe intestinal passageway.

The constriction step (a) and stimulation step (b) are suitablyperformed to constrict and stimulate the wall portion to an extent thatdepends on the flow restriction that is desired to be achieved in aspecific application of the method of the invention. Thus, in accordancewith a first flow restriction option, step (a) is performed byconstricting the wall portion, so that the flow in the intestinalpassageway is restricted but not stopped, and step (b) is performed bystimulating the constricted wall portion to cause contraction thereof,so that the flow in the intestinal passageway is further restricted butnot stopped. The method may further comprise sensing a physicalparameter of the patient and adjusting the intensity of the stimulationof the wall portion in response to the sensed parameter.

In accordance with a second flow restriction option, step (a) isperformed by constricting the wall portion, so that the flow in theintestinal passageway is restricted but not stopped, and step (b) isperformed by stimulating the constricted wall portion to causecontraction thereof, so that the flow in the intestinal passageway isstopped.

When using the method of the invention in accordance with the first orsecond options, the method may further comprise (c) ceaseing stimulatingthe wall portion to increase or allow the flow in the intestinalpassageway and (d) releasing the wall portion to restore the flow in theintestinal passageway.

In accordance with a third flow restriction option, step (a) isperformed by constricting the wall portion, so that the flow in theintestinal passageway is substantially stopped, and step (b) isperformed by stimulating the constricted wall portion to causecontraction thereof, so that the flow in the intestinal passageway iscompletely stopped. The method may further comprise (c) ceaseingstimulating the wall portion to allow the flow in the intestinalpassageway and (d) releasing the wall portion to restore the flow in theintestinal passageway.

For example, the third flow restriction option may be applied where theinvention is used for controlling fecal flow of an anal incontinentpatient. Between defecations, any portion of the incontinent patient'slarge or small intestines is gently constricted into a flattened shapeto at least almost stop the fecal flow in the intestines, and theflattened portion of the intestines is stimulated to insure that thefecal flow is completely stopped. By intermittently and individuallystimulating different areas of the wall portion the risk of injuring theintestines over time is significantly reduced or even eliminated, whichinsures that the effect of the stimulation is maintained over time. Whenthe patient wants to defecate, the stimulation is ceased and the portionof the intestines is released, whereby fecal matter may pass the portionof the intestines.

Where the constricted wall portion is stimulated to contract, so thatthe flow in the intestinal passageway is stopped, a first length of theconstricted wall portion and a second length of the constricted wallportion, which is located downstream of the first length, are suitablysimultaneously and cyclically stimulated, wherein the first length isprogressively stimulated in the upstream direction of the intestinalpassageway and the second length is progressively stimulated in thedownstream direction of the intestinal passageway.

Furthermore, when using the method of the invention in accordance withthe second and third options, the method may further comprise sensing aphysical parameter of the patient or functional parameter of implantedcomponents and adjusting the stimulation of the wall portion in responseto the sensed parameter. For example, the intensity of the stimulationof the wall portion may be increased in response to a sensed pressureincrease in the intestinal passageway, so that the flow in theintestinal passageway remains stopped when a pressure increase occurs inthe intestinal passageway. In particular, the method may comprisesensing a physical parameter of the patient's that relates to thepressure in the intestinal passageway, and controlling the stimulationof the wall portion in response to the sensed parameter. Any sensor forsensing a physical parameter of the patient, such as a pressure in thepatient's body that relates to the pressure in the intestinal passagewaymay be provided, wherein the stimulation is controlled in response tosignals from the sensor. Such a sensor may for example sense thepressure in the patient's abdomen, the pressure against the implantedconstriction device or the pressure on the intestines.

In accordance with a fourth restriction option, step (a) is performed byconstricting the wall portion, so that the flow in the intestinalpassageway is stopped. When needed, the wall portion is released torestore the flow in the intestinal passageway. Step (b) is onlyperformed by stimulating the constricted wall portion to causecontraction thereof, so that the flow in the intestinal passagewayremains stopped when a pressure increase occurs in the intestinalpassageway. The method may further comprise sensing a physical parameterof the patient's body, such as a pressure in the patient's body thatrelates to the pressure in the intestinal passageway, and controllingthe stimulation of the wall portion in response to the sensed parameter.Such a physical parameter may be a pressure in the patient's abdomen andthe sensor may be a pressure sensor.

In some applications of the method of the invention, continuousstimulation may over time change the physical properties of the tissueso that the tissue might be injured. Also, the effect of a continuousstimulation of the tissue wall may decrease over time. Therefore, step(b) is preferably performed by intermittently and individuallystimulating different areas of the wall portion of the intestines sothat the flow in the intestinal passageway continues to be restricted asdesired and each area of the wall portion essentially maintains itsnatural physical properties over time to prevent the area from beinginjured. Advantageously, each area of the wall portion is stimulatedduring successive time periods, each time period being short enough tomaintain over time satisfactory blood circulation in the area. Thus, theareas are stimulated so that an area that currently is not stimulatedwill have time to restore substantially normal blood circulation beforeit is stimulated again.

To maintain satisfactory blood circulation in the tissue wall of thepatient's intestines stimulation step (b) is suitably performed bystimulating one or more of different areas of the wall portion at atime, preferably by sequentially stimulating the different aeras of thewall portion or by shifting the stimulation from one area to anotherover time. Preferably, stimulation step (b) is performed by cyclicallypropagating the stimulation of the areas along the wall portion, forexample in accordance with a determined stimulation pattern.

The method of the invention may further comprise controlling, preferablyby the patient, the constriction and/or stimulation of the wall portionfrom outside the patient's body.

Generally, the method of the invention comprises sensing a physicalparameter of the patient and controlling, preferably automatically, theconstriction and/or stimulation of the wall portion in response to thesensed parameter.

The constriction step (a) may be performed by constricting any wallportions of a series of wall portions of the tissue wall, respectively,either in random or in accordance with a predetermined sequence. Thestimulation step (b) may be performed by stimulating any of theconstricted wall portions of the series of wall portions. Specifically,step (a) may be performed by constricting all of the wall portions ofthe series of wall portions, and step (b) may be performed bystimulating any constricted wall portions in random or in accordancewith a predetermined sequence to close the intestinal passageway.

Moving Intestinal Contents in the Intestinal Passageway or PreventinciMovement of Intestinal Contents in the Intestinal Passageway

It should be understood that any embodiment or part of embodimentdisclosed below in connection with moving fluid or other bodily matterin the lumen, or preventing the move of fluid or any bodily matter inthe lumen, for the constriction and stimulation devices combined in theconstriction/stimulation unit could be used for the separateconstriction device and separate stimulation device, where applicable.

The method of the present invention can be practised for actively movingthe intestinal contents in the intestinal passageway of a patient'sintestines. Thus, in the embodiments of the invention listed below,steps (a) and (b) are co-operated to move the intestinal contents in theintestinal passageway.

1) Step (a) is performed by constricting the wall portion to restrictthe flow in the intestinal passageway, and step (b) is performed bystimulating the constricted wall portion to close the intestinalpassageway either at an upstream end or a downstream end of theconstricted wall portion. The method further comprises (c) increasingthe constriction of the wall portion to move the intestinal contents inthe intestinal passageway.

2) Step (a) is performed by constricting the wall portion to restrictthe flow in the intestinal passageway, and step (b) is performed byprogressively stimulating the constricted wall portion to causeprogressive contraction of the wall portion to move the intestinalcontents in the intestinal passageway. The constricted wall portion isprogressively stimulated in the downstream or upstream direction of theintestinal passageway.

3) Step (a) is performed by varyingly constricting the wall portion tovary the flow in the intestinal passageway, and step (b) is performed byprogressively stimulating the constricted wall portion to causeprogressive contraction of the wall portion to move the intestinalcontents in the intestinal passageway. The constricted wall portion isprogressively stimulated in the downstream or upstream direction of theintestinal passageway.

4) Step (a) is performed by varyingly constricting different areas ofthe wall portion to cause progressive constriction of the wall portionin the downstream or upstream direction of the intestinal passageway,and the constricted wall portion is progressively stimulated to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion. The method may further compriseproviding at least one elongated constriction element extending alongthe wall portion, and controlling the elongated constriction element toprogressively constrict the wall portion in the downstream or upstreamdirection of the intestinal passageway. The elongated constrictionelement suitably comprises contact surfaces dimensioned to contact alength of wall portion, and the method may further comprise providing aplurality of stimulation elements distributed along the contactsurfaces, and controlling the stimulation elements to stimulate thedifferent areas of the wall portion along the length of the wallportion.

5) Step (a) is performed by constricting any one of a series of wallportions of the tissue wall to at least restrict the flow in theintestinal passageway, and step (b) is performed by stimulating theconstricted wall portion to close the intestinal passageway. The methodfurther comprises successively constricting the wall portions of theseries of wall portions to move the intestinal contents in theintestinal passageway in a peristaltic manner.

5a) In accordance with an alternative, the method further comprisesproviding at least one constriction element and at least one stimulationelement positioned on the constriction element, moving the constrictionelement along the intestines in the flow direction in the intestinalpassageway to successively constrict the wall portions of the series ofwall portions, and using the stimulation element to stimulate the wallportion constricted by the constriction element to close the intestinalpassageway. Suitably, the method further comprises cyclically moving theconstriction element along the wall portions of the series of wallportions.

5b) In accordance with another alternative, the method further comprisesproviding a plurality of constriction elements and stimulation elementspositioned on the constriction elements, moving each constrictionelement along the intestines to successively constrict the wall portionsof the series of wall portions, and using the stimulation elements tostimulate the wall portion constricted by any one of the constrictionelements to close the intestinal passageway. Suitably, the methodfurther comprises cyclically moving the constriction elements one afterthe other along the wall portions of the series of wall portions.Specifically, the method further comprises providing a rotor carryingthe constriction elements, and rotating the rotor so that eachconstriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller that rolls on the intestines to constrict the latter.

6) Step (a) is performed by constricting any wall portions of a seriesof wall portions of the tissue wall, respectively, wherein the wallportions of the series of wall portions are successively constrictedalong the intestines to move the intestinal contents in the intestinalpassageway of the patient's intestines. The stimulation step (b) isperformed by stimulating any constricted wall portions of the series ofwall portions.

7) Step (a) is performed by constricting wall portions of a series ofwall portions without completely closing the intestinal passageway, andstep (b) is performed by stimulating the constricted wall portions oneafter the other, so that the wall portions of the series of wallportions are successively contracted along the intestines to move theintestinal contents in the intestinal passageway of the patient'sintestines.

8) Step (a) is performed by constricting the wall portion at an upstreamor downstream end thereof to close the intestinal passageway. The methodfurther comprises (c) constricting the wall portion between the upstreamand downstream ends thereof, to move the fluid or other bodily mattercontained in the wall portion between the upstream and downstream endsthereof downstream or upstream in the intestinal passageway. Optionally,the method further comprises stimulating the wall portion between theupstream and downstream ends thereof, as (c) is performed.

8a) In accordance with an alternative, step (a) is performed byconstricting the wall portion at the upstream end thereof to restrictthe flow in the intestinal passageway, and step (b) is performed bystimulating the constricted wall portion at the upstream end to closethe intestinal passageway, whereby the intestinal contents contained inthe wall portion between the upstream and downstream ends thereof ismoved downstream in the intestinal passageway, as step (c) is performed.

8b) In accordance with another alternative, step (a) is performed byconstricting the wall portion at the downstream end thereof to restrictthe flow in the intestinal passageway, and step (b) is performed bystimulating the constricted wall portion at the downstream end to closethe intestinal passageway, whereby the intestinal contents contained inthe wall portion between the upstream and downstream ends thereof ismoved upstream in the intestinal passageway, as step (c) is performed.

Where the intestines are the small intestines, a particularly long wallportion of the intestines may be surgically prepared to extend in zigzagwith adjacent walls stitched together by two parallel rows of stitchesand with the adjacent walls cut through between the two rows ofstitches. As a result, the intestinal passageway of this long wallportion of the intestines can be significantly expanded. In this case, aconsiderably larger volume of fluid is moved in the intestines each timestep (a) and/or step (b) is performed.

To summarize a few preferred embodiments see below: In accordance withan alternative, step (a) is performed by constricting any wall portionsof a series of wall portions of the tissue wall of the intestines,respectively. In accordance with an alternative, the wall portions ofthe series of wall portions are constricted in random or in accordancewith a predetermined sequence. In accordance with an alternative, thewall portions of the series of wall portions are successivelyconstricted along the intestines to move the intestinal contents in theintestinal passageway of the patient's intestines or to prevent theintestinal contents to move in the lumen of the patient's intestines.

In accordance with an alternative, step (b) is performed by stimulatingany constricted wall portions of the series of wall portions. Inaccordance with an alternative, the wall portions of the series of wallportions are constricted in random or in accordance with a predeterminedsequence. In accordance with an alternative, wherein the wall portionsof the series of wall portions are successively constricted along theintestines to move the intestinal contents in the intestinal passagewayof the patient's intestines or to prevent the intestinal contents tomove in the lumen of the patient's intestines.

In accordance with an alternative, step (a) is performed by constrictingany wall portions of a series of wall portions of the tissue wall of theintestines, respectively, wherein the wall portions of the series ofwall portions are succesively constricted without completely closing theintestinal passageway, and step (b) is performed by stimulating theconstricted wall portions, so that the wall portions of the series ofwall portions are further constricted. In accordance with analternative, the wall portions of the series of wall portions areconstricted in random or in accordance with a predetermined sequence.

In accordance with an alternative, wherein the wall portions of theseries of wall portions are successively constricted along theintestines to move the intestinal contents in the intestinal passagewayof the patient's intestines or to prevent the intestinal contents tomove in the lumen of the patient's intestines.

In accordance with an alternative, step (a) is performed by constrictingall of the wall portions of the series of wall portions, and step (b) isperformed by stimulating any constricted wall portions so that the wallportions of the series of wall portions are further constricted.

In accordance with an alternative, the wall portions of the series ofwall portions are further constricted by the stimulation device inrandom or in accordance with a predetermined sequence.

In accordance with an alternative, the wall portions of the series ofwall portions are successively further constricted by the stimulationdevice along the intestines to move the intestinal contents in theintestinal passageway of the patient's intestines or to prevent theintestinal contents to move in the lumen of the patient's intestines.

In accordance with an alternative for all applicable alternatives, step(a) and step (b) are performed independently of each other or inaccordance with an alternative, step (a) and step (b) are performedsimultaneously.

In any of the above noted embodiments (1) to (8b), step (b) may beperformed by stimulating the wall portion with electric pulses.

Stimulation Modes

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time if the stimulation is not properlyperformed. The method of the present invention is performed to reduce oreven eliminate that risk. Thus, step (b) is performed by intermittentlystimulating different areas of the wall portion so that at least two ofthe areas are stimulated at different points of time. I.e., thestimulation is shifted from one area to another area over time. Inaddition, step (b) is performed by intermittently stimulating the areasof the wall portion so that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before it is stimulated again. Furthermore, step (b)is performed by intermittently stimulating the areas during successivetime periods, wherein each time period is short enough to maintainsatisfactory blood circulation in the area until the laps of the timeperiod. This gives the advantage that the method of the presentinvention provides continuous stimulation of the wall portion of theintestines to achieve the desired flow control while essentiallymaintaining over time the natural physical properties of the intestineswithout risk of injuring the intestines.

Also, by physically changing the places of stimulation on the intestinesover time as described above it is possible to create an advantageouschanging stimulation pattern on the intestines, in order to achieve adesired flow control.

To achieve the desired reaction of the tissue wall during thestimulation thereof, step (b) may be performed by stimulating the wallportion with, preferably cyclically, varying stimulation intensity.

In a main embodiment of the invention, step (b) is performed byintermittently stimulating the wall portion with pulses, preferably inthe form of pulse trains. The pulse trains can be configured in manydifferent ways by varying pulse parameters. Thus, the pulse amplitudesof the pulses of the pulse trains, the off time periods between theindividual pulses of each pulse train and the width and repetitionfrequency of each pulse may be varied. Also the off time periods betweenthe pulse trains may be varied, wherein each off time period between thepulse trains is kept long enough to restore substantially normal bloodcirculation in each area of the wall portion, when the area is notstimulated during the off time periods. Furthermore, the repetitionfrequency of the pulses of the pulse trains and the length and number ofpulses of each pulse train may be varied.

As mentioned above, for reasons of maintaining over time the effect ofstimulation, it is preferable that different areas of the wall portionare intermittently and individually stimulated. In consequence, step (b)may be performed by stimulating one or more of the areas at a time withpulses, by cyclically propagating the stimulation of the areas withpulses along the wall portion, and/or by propagating the stimulation ofthe areas with pulses in accordance with a determined stimulationpattern. In case the off time periods between pulse trains thatstimulate the respective area of the wall portion are varied, it ispreferable that each off time period between the pulse trains iscontrolled to last long enough to restore substantially normal bloodcirculation in the area when the latter is not stimulated during the offtime periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, step (b) isperformed by electrically stimulating the wall portion, preferably withelectric pulses to cause contraction of the wall portion. Thisembodiment is particularly suited for applications in which thepatient's wall portion includes muscle fibers that react to electricalstimula. Thus, the wall portion that includes the muscle fibers isstimulated with such electric pulses, preferably in the form of electricpulse trains, when the wall portion is in the constricted state, tocause contraction of the wall portion. Of course, the configuration ofthe electric pulse trains may be similar to the above described pulsetrains and different areas of the wall portion may be electricallystimulated in the same manner as described above.

In accordance with the preferred embodiment, the method of the inventioncomprises providing at least one, preferably a plurality of electricalelements, such as electrodes, engaging and stimulating the wall portionwith electric pulses. Optionally, the electrical elements may be placedin a fixed orientation relative to one another. The method compriseselectrically energizing the electrical elements, preferably bycyclically energizing each element with electric pulses. The electricalelements may be energized so that the electrical elements are energizedone at a time in sequence, or so that a number or groups of theelectrical elements are energized at a time. Also, groups of electricalelements may be sequentially energized, either randomly or in accordancewith a predetermined pattern.

The method may further comprise applying the electrical elements on thepatient's wall portion so that the electrical elements form any patternof electrical elements, preferably an elongate pattern of electricalelements extending lengthwise along the wall portion and the elementsabut the respective areas of the wall portion. The electrical elementsmay be successively energized along the elongate pattern of electricalelements in a direction opposite to or in the same direction as that ofthe flow in the patient's intestinal passageway. Optionally, theelectrical elements may be successively energized along the elongatepattern of electrical elements from a position substantially at thecenter of the constricted wall portion towards both ends of the elongatepattern of electrical elements. Where the intestinal passageway of theintestines is to be kept closed for a relatively long time, theelectrical elements may be energized so that energized electricalelements form two waves of energized electrical elements thatsimultaneously advance from the center of the constricted wall portionin two opposite directions towards both ends of the elongate pattern ofelectrical elements. Such waves of energized electrical elements can berepeated over and over again without harming the intestines and withoutmoving fluid or gas in any direction in the intestinal passageway of theintestines.

The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the intestines. Eachrow of electrical elements may form a straight, helical or zig-zag pathof electrical elements, or any form of path. The electrical elements maybe energized so that the electrical elements currently energized form atleast one group of adjacent energized electrical elements, wherein theelements in the group of energized electrical elements form a path ofenergized electrical elements extending at least in part around thepatient's intestines, preferably completely around the patient'sintestines. Alternatively, the elements in the group of energizedelectrical elements form two paths of energized electrical elementsextending on mutual sides of the patient's intestines or more than twopaths of energized electrical elements extending on different sides ofthe patient's intestines, preferably at least substantially transverseto the flow direction in the intestinal passageway of the intestines.

In an embodiment of the invention, the electrical elements form aplurality of groups of elements, wherein the groups form a series ofgroups extending along the patient's intestines in the flow direction inthe patient's intestinal passageway. The electrical elements of eachgroup of electrical elements may form a path of elements extending atleast in part around the patient's intestines. In a first alternative,the electrical elements of each group of electrical elements may formmore than two paths of elements extending on different sides of thepatient's intestines, preferably substantially transverse to the flowdirection in the patient's intestinal passageway. The groups ofelectrical elements in the series of groups may be energized in randomor in accordance with a predetermined pattern. Alternatively, the groupsof electrical elements in the series of groups may be successivelyenergized in a direction opposite to or in the same direction as that ofthe flow in the patient's intestinal passageway, or in both saiddirections starting from a position substantially at the center of theconstricted wall portion. For example, groups of energized electricalelements may form advancing waves of energized electrical elements, asdescribed above. I.e., the groups of electrical elements may beenergized so that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

Thermal Stimulation

In accordance with an embodiment of the invention, stimulation step (b)is performed by thermally stimulating the wall portion. Thus, the wallportion may be cooled, when the wall portion is constricted, to causecontraction of the wall portion. For example, the wall portion may beconstricted to at least restrict the flow in the intestinal passageway,and the constricted wall portion may be cooled to cause contractionthereof, so that the flow in the intestinal passageway is at leastfurther restricted, or further restricted but not stopped, or stopped.Alternatively, the wall portion may be heated, when the wall portion isconstricted and contracted, to cause expansion of the wall portion.Where applicable, thermal stimulation may be practised in any of theembodiments of the present invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Constriction and Stimulation Devices

It should be understood that any embodiment or part of embodiment forthe combined stimulation device and constriction device, could be used,where applicable, for any one of the devices as a stand alone device.

Generally, the method of the invention comprises providing aconstriction device that constricts the wall portion, a stimulationdevice that stimulates the constricted wall portion and a control devicethat controls the constriction device and/or the stimulation device. Themethod comprises operating the control device from outside the patient'sbody, preferably by using the control device to wirelessly control theconstriction device and/or stimulation device. The wireless control ispreferably performed in a non-magnetic manner, whereby implantedmagnetic devices can be avoided. Suitably, the control device comprisesa hand-held wireless remote control operated by the patient.

Alternatively, the control device comprises a manually operable switchfor switching on and off the constriction device and/or stimulationdevice. In this case, the method comprises subcutaneously implanting theswitch in the patient and manually operating the the implanted switchfrom outside the patient's body.

In an embodiment of the invention, the control device comprises aprogrammable internal control unit, such as a microprocessor, and themethod comprises implanting in the patient the internal control unit andcontrolling by the internal control unit the constriction device and/orstimulation device. The control device may also comprise an externalcontrol unit outside the patient's body. In this case, the methodcomprises controlling by the external control unit the constrictiondevice and/or stimulation device and, optionally, using the externalcontrol unit to program the implanted internal control unit. Theinternal control unit may be programmable for controlling theconstriction device and/or stimulation device over time, for example inaccordance with an activity schedule program.

The constriction of the wall portion can be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the intestinal passageway is obtained.

Sensor Controlled Constriction and/or Stimulation

It should be understood that any embodiment or part of embodimentdisclosed below in connection with sensor control of the constrictionand stimulation devices combined in the constriction/stimulation unitcould be used for the separate constriction device and separatestimulation device, where applicable.

In an embodiment of the invention, the method comprises implanting atleast one sensor and controlling by the control device the constrictiondevice and/or the stimulation device in response to signals from thesensor. Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, functional parameter of theapparatus, or functional parameter of a medical implant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing intestinal motion, i.e.natural contractions, such as intestinal contractions, pressure sensorsfor sensing pressure in the intestines, strain sensors for sensingstrain of the intestines, flow sensors for sensing fluid flow in theintestinal passageway of the intestines, spectro-photometrical sensors,Ph-sensors for acidity or alkalinity of the fluid in the intestinalpassageway of the intestines, oxygen-sensors sensors for sensing theoxygen content of the fluid in the intestinal passageway of theintestines, or sensors for sensing the distribution of the stimulationon the stimulated intestines. Any conceivable sensors for sensing anyother kind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters ofimplanted components may also be used for the control of theconstriction device and/or the stimulation device. For example sensorsfor sensing electric parameters of implanted electric components, orsensors for sensing the performance of implanted motors or the like.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the intestinal passageway of the patient's bodily intestines. In thiscase, the method suitably comprises operating the control device tocontrol the constriction device to change the constriction of thepatient's wall portion in response to the pressure sensor sensing apredetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the intestinal passageway during different time periods of the day.In case a sensor of any of the above-described types for sensing aphysical or functional parameter is provided, either the clock mechanismis used for controlling the constriction device and/or stimulationdevice provided that the parameter sensed by the sensor does notoverride the clock mechanism, or the sensor is used for controlling theconstriction device and/or stimulation device provided that the clockmechanism does not override the sensor. Suitably, the control deviceproduces an indication, such as a sound signal or displayed information,in response to signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism. Alternatively, the controldevice may comprise an external control unit outside the patient's bodyfor controlling the constriction device and/or stimulation device inresponse to signals from the sensor.

Constriction of Patient's Intestines

It should be understood that any embodiment or part of embodimentdisclosed below in connection with constricting the patient's organcould be used for the separate constriction device and separatestimulation device, where applicable.

Method step (a) may be performed in many different ways. Thus, step (a)may be performed by:

(1)—constricting the wall portion so that the through-flow area of theintestinal passageway assumes a size in the constricted state smallenough to cause the constricted wall portion to contract to stop theflow in the intestinal passageway when step (b) is performed;

(2)—bending the wall portion;

(3)—clamping the wall portion between at least two elements positionedon different sides of the intestines;

(4)—clamping the intestines between an element and the bone or tissue ofthe patient;

(5)—rotating at least two elements positioned on different sides of theintestines;

or

(6)—clamping the intestines between at least two articulated clampingelements positioned on different sides of the intestines.

In the above noted alternatives (1) to (6) of method step (a), theconstriction of the wall portion of the intestines may be changed eithermechanically or hydraulically. For many applications of the presentinvention, step (a) is suitably performed so that the through-flow areaof the intestinal passageway assumes a size in the constricted statethat is small enough to enable the stimulation during step (b) tocontract the wall portion of the intestines to stop the flow in theintestinal passageway.

Where the constriction of the wall portion is hydraulically changed, themethod of the invention may further comprise implanting in the patient areservoir containing a predetermined amount of hydraulic fluid, and aconstriction device engaging the wall portion and having anexpandable/contractible cavity, wherein step (a) is performed bydistributing hydraulic fluid from the reservoir to increase the volumeof the cavity to constrict the wall portion, and by distributinghydraulic fluid from the cavity to the reservoir to decrease the volumeof the cavity to release the wall portion. The cavity may be defined bya balloon of the constriction device that abuts the tissue wall portionof the patient's intestines, so that the patient's wall portion isconstricted upon expansion of the cavity and released upon contractionof the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the following embodiments of the invention are conceivable.

1) The reservoir comprises first and second wall portions, and step (a)is performed by displacing the first and second wall portions relativeto each other to change the volume of the reservoir, so that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1 a) At least one of a magnetic device, a hydraulic device or anelectric control device displaces the first and second wall portions ofthe reservoir.

2) A pump is provided for pumping fluid between the reservoir and thecavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

2a1) The first and second activation members are operable by manualmanipulation thereof.

2a2) At least one of the activation members operates when subjected toan external predetermined pressure.

2a3) At least one of the first and second activating members is operableby magnetic means, hydraulic means, or electric control means.

2b) A fluid conduit between the pump and the cavity is provided, whereinthe reservoir forms part of the conduit. The conduit and pump are devoidof any non-return valve. The reservoir forms a fluid chamber with avariable volume, and the pump distributes fluid from the chamber to thecavity by a reduction in the volume of the chamber and withdraws fluidfrom the cavity by an expansion of the volume of the chamber. A motor isprovided for driving the pump, wherein the pump comprises a movable wallof the reservoir for changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, hydraulic fluid is distributedbetween the reservoir and the cylinder/piston mechanism to adjust theconstriction device.

3) The method further comprises implanting a reverse servo operativelyconnected to the hydraulic means. The term “reverse servo” is to beunderstood as a mechanism that transfers a strong force acting on amoving element having a short stroke into a weak force acting on anothermoving element having a long stroke; i.e., the reverse function of anormal servo mechanism. Thus, minor changes in the amount of fluid in asmaller reservoir could be transferred by the reverse servo into majorchanges in the amount of fluid in a larger reservoir.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operated to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir, sothat the volume of the main reservoir is changed when the volume of theexpandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the method comprises dimensioning the servo and mainreservoirs, so that when the volume of the servo reservoir is changed bya relatively small amount of servo fluid, the volume of the mainreservoir is changed by a relatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaced relative to each other by manualmanipulation, a magnetic device, a hydraulic device, or an electriccontrol device to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means includes a hydraulically operablemechanical construction, the reverse servo described above may be used.In a further embodiment of the invention, the hydraulic means includefirst and second hydraulically interconnected expandable/contractiblereservoirs. The first reservoir is operatively connected to theconstriction device, so that the constriction device changes theconstriction of the patient's wall portion upon expansion or contractionof the first reservoir. By changing the volume of the second reservoirhydraulic fluid is distributed between the two reservoirs, so that thefirst reservoir is either expanded or contracted. This embodimentrequires no non-return valve in the fluid communication conduits betweenthe two reservoirs, which is beneficial to long-term operation of thehydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, so thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements extending along the wall portionon different sides of the intestines. The hydraulic means, which mayinclude the reverse servo described above, hydraulically moves theelongated clamping elements towards the intestines to constrict the wallportion of the intestines. For example, the constriction device may havehydraulic chambers in which the clamping elements slide back and forth,and the hydraulic means may also include a pump and an implantablereservoir containing hydraulic fluid. The pump distributes hydraulicfluid from the reservoir to the chambers to move the clamping elementsagainst the wall portion, and distributes hydraulic fluid from thechambers to the reservoir to move the clamping elements away from thewall portion.

Energy Supply

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the power of the constriction andstimulation devices combined in the constriction/stimulation unit couldbe used for the separate constriction device and separate stimulationdevice, where applicable.

Generally, method step (a) is performed by using the constriction deviceand step (b) is performed by using the stimulation device, wherein themethod further comprises forming the constriction and stimulationdevices in an operable constriction/stimulation unit.

In a simple form of the invention, the method comprises implanting asource of energy, such as a battery, rechargeable battery oraccumulator, releasing energy from the source of energy and using thereleased energy in connection with the operation of theconstriction/stimulation unit.

In a more sophisticated form of the invention, which is preferable, themethod comprises transmitting wireless energy from outside the patient'sbody to inside the patient's body and using the transmitted wirelessenergy in connection with the operation of the constriction/stimulationunit.

Transmission of Wireless Energy

It should be understood that any embodiment or part of embodimentdisclosed below in connection with wireless control or power of theconstriction and stimulation devices combined in theconstriction/stimulation unit could be used for the separateconstriction device and separate stimulation device, where applicable.

The wireless energy may be directly used in connection with theoperation of the constriction/stimulation unit, as the wireless energyis being transmitted. For example, the wireless energy may betransmitted in the form of an electric, an electromagnetic or a magneticfield, or a combination thereof, or electromagnetic waves for directpower of the constriction/stimulation unit. For example, where anelectric motor or pump operates the constriction device of theconstriction/stimulation unit, wireless energy in the form of a magneticor an electromagnetic field may be used for direct power of the motor orpump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy. Such components may include coilsintegrated in the motor or pump.

The wireless energy is suitably transmitted in pulses or digital pulses,or a combination of pulses and digital pulses.

Preferably, the wireless energy is transmitted in at least one wirelesssignal, suitably a wave signal. The wave signal may comprise anelectromagnetic wave signal including one of an infrared light signal, avisible light signal, an ultra violet light signal, a laser signal, amicrowave signal, a radio wave signal, an x-ray radiation signal, and agamma radiation signal. Alternatively, the wave signal may comprise asound or an ultrasound wave signal. The wireless signal may be a digitalor analogue signal, or a combination of a digital and analogue signal.

In accordance with a particular embodiment of the invention, thewireless energy is not for direct use in connection with the operationof the constriction/stimulation unit. In this embodiment the wirelessenergy comprises energy of a first form, which is transmitted intoenergy of a second form suited to operate the constriction/stimulationunit. Typically, the energy of the second form is different from theenergy of the first form. For example, the wireless energy of the firstform may comprise sound waves, whereas the energy of the second form maycomprise electric energy. Optionally, one of the energy of the firstform and the energy of the second form may comprise magnetic energy,kinetic energy, sound energy, chemical energy, radiant energy,electromagnetic energy, photo energy, nuclear energy or thermal energy.Preferably, one of the energy of the first form and the energy of thesecond form is non-magnetic, non-kinetic, non-chemical, non-sonic,non-nuclear or non-thermal.

Transforming Wireless Energy

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the control or energizing of theconstriction and stimulation devices combined in theconstriction/stimulation unit could be used for the separateconstriction device and separate stimulation device, where applicable.

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. Optionally, oneof the energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function different from or similar tothe energy-transmission device. Advantageously, the energy-transformingdevice comprises at least one element, such as at least onesemiconductor, having a positive region and a negative region, whenexposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy of the first form may directly or indirectly be transformedinto the energy of the second form. The method of the invention maycomprise providing a motor for operating the constriction device andpowering the motor with the energy of the second form. The constrictiondevice may be operable to perform at least one reversible function andthe method may comprise reversing the function by using the motor. Forexample, the method may comprise shifting the polarity of the energy ofthe second form to reverse the motor.

The motor may be directly powered with the transformed energy, as theenergy of the second form is being transformed from the energy of thefirst form. Preferably, the constriction/stimulation unit is directlyoperated with the energy of the second form in a non-magnetic,non-thermal or non-mechanical manner.

Normally, the implanted constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Therefore, theenergy of the first form may be transformed into a direct current orpulsating direct current, or a combination of a direct current andpulsating direct current. Alternatively, the energy of the first formmay be transformed into an alternating current or a combination of adirect and alternating current.

The method of the invention may comprise implanting in the patient aninternal source of energy, and supplying energy from the internal sourceof energy for the operation of the constriction/stimulation unit. Themethod may further comprise implanting in the patient a switch operableto switch from an “off” mode, in which the internal source of energy isnot in use, to an “on” mode, in which the internal source of energysupplies energy for the operation of the constriction/stimulation unit,and/or for energizing implanted electronic components of theconstriction/stimulation unit. The switch may be operated by the energyof the first form or by the energy of the second form. The describedswitch arrangement reduces power consumption of theconstriction/stimulation unit between operations.

The internal source of energy may store the energy of the second form.In this case, the internal source of energy suitably comprises anaccumulator, such as at least one capacitor or at least one rechargeablebattery, or a combination of at least one capacitor and at least onerechargeable battery. Where the internal source of energy is arechargeable battery it may be charged only at times convenient for thepatient, for example when the patient is sleeping. Alternatively, theinternal source of energy may supply energy for the operation of theconstriction/stimulation unit but not be used for storing the energy ofthe second form. In this alternative, the internal source of energy maybe a battery and the switch described above may or may not be provided.

Suitably, the method of the invention may comprise implanting astabilizer for stabilizing the energy of the second form. Where theenergy of the second form comprises electric energy the stabilizersuitably comprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Control of Constriction/Stimulation Unit

It should be understood that any embodiment or part of embodimentdisclosed below in connection with the control of the constriction andstimulation devices combined in the constriction/stimulation unit couldbe used for the separate constriction device and separate stimulationdevice, where applicable.

Although the constriction device of the constriction/stimulation unitmay normally keep the patient's wall portion in the constricted state,in most applications using the present invention there will be dailyadjustments of the constriction device. Therefore, in a preferredembodiment of the invention, the constriction device is adjustable toenable changing the constriction of the patient's wall portion asdesired and the control device controls the constriction device tochange the constriction of the wall portion.

The method of the invention suitably comprises operating the controldevice by the patient. In a simple form the control device comprises amanually operable switch for switching on and off theconstriction/stimulation unit, and the method further comprisessubcutaneously implanting the switch in the patient. It is preferable,however, that the control device comprises a hand-held wireless remotecontrol operable by the patient from outside the patient's body tocontrol the constriction/stimulation unit to adjust the stimulationintensity and/or adjust the constriction of the wall portion. Thewireless remote control is suitably designed for application on thepatient's body like a wristwatch.

In some applications of the invention, the constriction device of theconstriction/stimulation unit may be designed to normally keep thepatient's wall portion in the constricted state. I.e., afterimplantation the constriction device all the time keeps the wall portionconstricted. In this case, the control device may be used when needed,conveniently by the patient, to control the stimulation device of theconstriction/stimulation unit to stimulate the constricted tissue wallportion, preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, so that the flow in the intestinalpassageway is at least further restricted or stopped, and to control thestimulation device to cease the stimulation. More precisely, the methodof the invention may comprise operating the control device by thepatient to

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow in the intestinalpassageway and control the stimulation device in a second mode to ceasethe stimulation of the wall portion to increase the flow in theintestinal passageway; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow in the intestinal passagewayand control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the intestinalpassageway.

Either the first mode or the second mode may be temporary.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above signals may comprise wave signals, such as a sound wavesignal, an ultrasound wave signal, an electromagnetic wave signal, aninfrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal or a gamma radiation signal.

Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

Operation of Constriction/Stimulation Unit

It should be understood that any embodiment or part of embodiment foroperating the combined stimulation device and constriction device, couldbe used, if applicable, for any one of the devices as a stand alonedevice.

The method of the invention may comprise implanting in the patient anoperation device, and operating the constriction/stimulation unit withthe operation device. A magnet may be provided, wherein the methodcomprises using the magnet to activate the operation device from outsidethe patient's body. The operation device suitably comprises a motorwhich is powered with energy released from a source of energy, such as abattery. Although the constriction/stimulation unit in embodimentsdescribed above suitably is designed as a single piece, which is mostpractical for implantation, it should be noted that as an alternativethe constriction device and stimulation device of theconstriction/stimulation unit could be designed as separate pieces.

Laparoscopic Method

The present invention also provides a first method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

inserting a needle like tube into the cavity of the patients body,

filling the cavity with gas thereby expanding the abdominal cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the intestines,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the intestines,

using the constriction device to gently constrict the wall portion ofthe intestines to influence the flow in the intestines, and

using the stimulation device to stimulate the constricted wall portionto

cause contraction of the wall portion to further influence the flow inthe intestines.

The present invention also provides a second method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the intestines,

placing a stimulation device in the dissected area in operativeengagement with the intestines, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the intestines.

The present invention also provides a third method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the intestines,

placing a constriction device in the dissected area in operativeengagement with the intestines,

using the constriction device to constrict the wall portion of theintestines to influence the flow in the intestines.

The present invention also provides a fourth method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the intestines,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the intestines, using the constrictiondevice to gently constrict the wall portion of the intestines toinfluence the flow in the intestines, and

using the stimulation device to stimulate the constricted wall portionto cause contraction of the wall portion to further influence the flowin the intestines.

The present invention also provides a fifth method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the intestines,

placing a stimulation device in the dissected area in operativeengagement with the intestines, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the intestines.

The present invention also provides a sixth method for controlling aflow of intestinal contents in the intestinal passageway formed by atissue wall of a patient's intestines. The method comprises the stepsof:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the intestines,

placing a constriction device in the dissected area in operativeengagement with the intestines, and

using the constriction device to constrict the wall portion of theintestines to influence the flow in the intestines.

In all of the above-noted methods 1-6 the cavity may constitute at leastone of an abdominal cavity, a cavity in the pelvic region, aretroperitoneal cavity, a cavity in human soft tissue such as muscle,fat and fibrotic tissue.

The present invention also provides another laparoscopic method.Accordingly, there is provided a method for controlling a flow ofintestinal contents in the intestinal passageway of a patient'sintestines formed by a tissue wall of a patient's intestines. The methodcomprises the steps of:

inserting a needle like tube into the abdomen of the patients body,

filling the abdomen with gas thereby expanding the abdominal cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the abdomen,

inserting a dissecting tool through any of the trocars and dissecting anarea of at least one portion of the tissue wall of the intestines,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the intestines,

using the constriction device to gently constrict the wall portion ofthe intestines to influence the flow in the intestinal passageway, and

using the stimulation device to stimulate the constricted wall portionto

cause contraction of the wall portion to further influence the flow inthe intestinal passageway.

The method further comprises implanting a powered operation device foroperating the constriction device. The operation device may comprise apowered hydraulic operation device or an electrically powered operationdevice, such as an electric motor.

The method further comprises transmitting wireless energy for poweringthe operation device, and when desired to influence the flow in thepatient's intestines, powering the operation device with the transmittedenergy to operate the constriction device.

The method further comprises implanting a source of energy in thepatient, providing an external source of energy, controlling theexternal source of energy to release wireless energy, transforming thewireless energy into storable energy, such as electric energy,non-invasively charging the implanted source of energy with thetransformed energy, and controlling the implanted source of energy fromoutside the patient's body to release energy for use in connection withthe operation of the constriction device and/or stimulation device. Thewireless energy is transformed into a storable energy different from thewireless energy.

Alternatively, the method further comprises providing a source of energyoutside the patient's body, controlling the external source of energyfrom outside the patient's body to release wireless energy, and usingthe released wireless energy for operating the constriction deviceand/or stimulation device. The wireless energy may be transformed intoelectrical energy inside the patient's body by an implantedenergy-transforming device, wherein the electrical energy is used inconnection with the operation of the constriction device and/orstimulation device. The electrical energy may be directly used inconnection with the operation of the constriction device and/orstimulation device, as the transforming device transforms the wirelessenergy into the electrical energy. The external source of energy may becontrolled from outside the patient's body to release non-magneticwireless energy, wherein the released non-magnetic wireless energy isused for operating the constriction device and/or stimulation device.Alternatively, the external source of energy may be controlled fromoutside the patient's body to release electromagnetic wireless energy,wherein the released electromagnetic wireless energy is used foroperating the constriction device and/or stimulation device.

Feed Back Related to the Wireless Energy

The following embodiments are related to feed back information relatedto an energy balance either comparing;

-   -   a) the amount of energy received by the internal energy source        compared to the energy used by the constriction device and/or        stimulation device, or    -   b) The amount of energy received by the internal energy source        and the amount of energy transmitted by the external energy        source.

Several alternatives of the method of the present invention aredisclosed below and may except being correlated directly to theconstriction device and/or stimulation device also be included in theoperating method. These methods are valid for use both with thestimulation device and constriction device separate or in combination.

A method for controlling the transmission of wireless energy comprisingan internal energy source, wherein said wireless energy is transmittedfrom an external energy source located outside the patient and isreceived by the internal energy source located inside the patient, theinternal energy source being connected to the constriction device and/orstimulation device for directly or indirectly supplying received energythereto, the method comprising the steps of:

-   -   determining an energy balance between the energy received by the        internal energy source and the energy used for the constriction        device and/or stimulation device, and    -   controlling the transmission of wireless energy from the        external energy source, based on the determined energy balance.

A method, wherein the wireless energy is transmitted inductively from aprimary coil in the external energy source to a secondary coil in theinternal energy receiver.

A method, wherein a change in said energy balance is detected, and thetransmission of wireless energy is controlled based on said detectedenergy balance change.

A method, wherein a difference is detected between energy received bysaid internal energy receiver and energy used for a medical device, andthe transmission of wireless energy is controlled based on said detectedenergy difference.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy balance change implies that the energy balance isincreasing, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to a detected change rate.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy difference implies that the received energy isgreater than the used energy, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to the magnitude of said detected energy difference.

A method, wherein the energy used for the constriction device and/orstimulation device is stored in at least one energy storage device ofthe device.

A method, wherein substantially all the energy used for the constrictiondevice and/or stimulation device is consumed to operate the device.

A method, wherein the energy is consumed after being stabilised in atleast one energy stabilising unit of the device.

A method, wherein the energy used for the constriction device and/orstimulation device is stored in at least one energy storage device ofthe device.

A method, wherein substantially all the energy used for the constrictiondevice and/or stimulation device i is consumed to operate the device.

A method, wherein the energy is consumed after being stabilised in atleast one energy stabilising unit of the device.

A method of controlling transmission of wireless energy supplied to atleast one of the constriction and stimulation devices, comprising aninternal energy source located inside the patient, connected to theconstriction device and/or stimulation device for directly or indirectlysupplying received energy thereto, the method comprising the steps of:

-   -   determining an energy balance between the energy sent by the        external energy source and the energy received by the internal        energy source, and    -   controlling the transmission of wireless energy from the        external energy source, based on the determined energy balance.

A method, wherein the wireless energy is transmitted inductively from aprimary coil in the external energy source to a secondary coil in theinternal energy receiver.

A method, wherein a change in said energy balance is detected, and thetransmission of wireless energy is controlled based on said detectedenergy balance change.

A method, wherein a difference is detected between the energy sent bythe external energy source and the energy received by said internalenergy receiver, and the transmission of wireless energy is controlledbased on said detected energy difference.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy balance change implies that the energy balance isincreasing, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to a detected change rate.

A method, wherein the amount of transmitted wireless energy is decreasedif the detected energy difference implies that the received energy isgreater than the used energy, or vice versa.

A method, wherein the decrease/increase of energy transmissioncorresponds to the magnitude of said detected energy difference.

A method of controlling transmission of wireless energy, wherein saidwireless energy being transmitted by means of a primary coil in theexternal energy source and received inductively by means of a secondarycoil in an internal energy source, the internal energy source beingconnected to the medical device for directly or indirectly supplyingreceived energy thereto, wherein feedback control information (S) istransferred from the secondary coil to the primary coil by switching thesecondary coil on and off to induce a detectable impedance loadvariation in the primary coil encoding the feedback control information,wherein the feedback control information relates to the energy receivedby the internal energy source and is used for controlling thetransmission of wireless energy from the external energy source.

The apparatus, wherein the external energy source further comprises anelectronic circuit for comparing the feedback information with theamount of energy transmitted by the external energy source.

The method, wherein the electronic circuit comprises an analyzeranalyzing the amount of energy being transmitted and receiving thefeedback information related to the amount of energy received in thereceiver, and determining the energy balance by comparing the amount oftransmitted energy and the feedback information related to the amount ofreceived energy.

The method, wherein the external energy source is adapted to use saidfeedback information adjusting the level of said transmitted energy.

A method of controlling transmission of wireless energy, wherein saidwireless energy being transmitted by means of a primary coil in anexternal energy source and received inductively by means of a secondarycoil in an internal energy source, the internal energy receiver beingconnected to the medical device for directly or indirectly supplyingreceived energy thereto, wherein feedback control information istransferred from the secondary coil to the primary coil by switching thesecondary coil on and off to induce a detectable impedance loadvariation in the primary coil encoding the feedback control information,where the feedback control information relates to said energy balance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, 1D and 1E schematically illustrate different states ofoperation of a general embodiment of an apparatus used for practicingthe method according to the present invention.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment.

FIG. 2 is a longitudinal cross-section of an embodiment of the apparatusof FIG. 1 including a constriction device and an electric stimulationdevice.

FIG. 3 is a cross-section along line II-II in FIG. 2.

FIG. 4 is the same cross-section shown in FIG. 3 but with the apparatusin a different state of operation.

FIGS. 5A, 5B and 5C are cross-sections of the embodiment of FIG. 2showing different states of operations with the apparatus applied on atissue wall of a patient's intestines.

FIGS. 6A, 6B and 6C are cross-sections of a modification of theembodiment of FIG. 2 showing different states of operations with theapparatus applied on a tissue wall of a patient's intestines.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the apparatus is constrictinga tissue wall of a patient's intestines.

FIG. 8A is a pulse/time diagram showing electric stimulation pulsesgenerated by the apparatus used for practicing the method of theinvention, wherein the electric pulses are for stimulating a tissue wallof a patient's intestines.

FIG. 8B is pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A, in which pulses of mixed frequenciesand/or amplitudes are employed.

FIGS. 9A and 9B show two pulse/time diagrams, respectively, representingelectric stimulation of two different areas of the tissue wall withpulses forming pulse trains.

FIGS. 10A and 10B show the pulse/time diagrams of FIGS. 9A and 9B withmodified pulse trains.

FIG. 11A is a longitudinal cross-section of an embodiment of anapparatus used for practicing the method of the invention, where theapparatus includes a thermal stimulation device and the apparatus isconstricting a tissue wall of a patient's intestines.

FIG. 11B is the same embodiment of FIG. 11A with the thermal stimulationdevice activated.

FIG. 12A is a schematic view of hydraulic operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 12B shows the embodiment of FIG. 12A with the constriction deviceconstricting a tissue wall of a patient's intestines.

FIG. 13A is a schematic view of mechanical operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 13B shows the embodiment of FIG. 13A with the constriction deviceconstricting a tissue wall of a patient's intestines.

FIG. 13C shows a modification of the embodiment of FIG. 13B.

FIG. 14A illustrates an apparatus used for practicing the method of theinvention where the apparatus is applied on the small intestines of acolostomy patient having a stoma opening in the abdomen.

FIG. 14B illustrates an apparatus used for practicing the method of theinvention where the apparatus is applied on the small intestines of acolostomy patient having the small intestines ending at the patient'sanus.

FIG. 15 is a schematic sectional view of a mechanically operablenon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 16 and 17 are cross-sectional views taken along the lines XVI-XVIand XVII-XVII, respectively, of FIG. 15.

FIG. 18 schematically shows an alternative design of the embodiment ofFIG. 15;

FIG. 19 schematically illustrates a motor arrangement for the embodimentaccording to FIG. 18;

FIGS. 20 and 21 are schematic sectional views of two alternative designsof non-inflatable constriction devices used for practicing the method ofthe invention.

FIGS. 22 and 23 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 21;

FIG. 24 is a schematic view of a further alternative design of anon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 25 and 26 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 24;

FIG. 27 is a schematic view of another alternative design of anon-inflatable constriction device used for practicing the method of theinvention.

FIGS. 28 and 29 are schematic sectional views, respectively, of yetanother alternative design of a non-inflatable constriction device usedfor practicing the method of the invention.

FIG. 30A is a schematic view of a hydraulically operable inflatableconstriction device for used for practicing the method of the invention.

FIG. 30B is the same embodiment shown in FIG. 30A with the constrictiondevice inflated.

FIGS. 31A, 31B, 31C and 31D are block diagrams illustrating fourdifferent principles for hydraulic operation of the constriction deviceshown in FIG. 30A.

FIG. 32 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor.

FIGS. 33A and 33B are perspective views of a reverse servo in accordancewith a particular embodiment of the hydraulic operation principle shownin FIG. 31C.

FIG. 34 is a schematic view of another hydraulically operableconstriction device for practicing the method according to the presentinvention.

FIG. 35A illustrates the constriction device of FIG. 34 in a constrictedstate.

FIG. 35B illustrates the constriction device of FIG. 34 in a releasedstate.

FIGS. 36A-36E schematically illustrate different operation stages of anembodiment of the invention, in which a constriction device and astimulation device used for practicing the method of the inventionco-operate to move the intestinal contents in the intestinal passagewayof a patient's intestines.

FIG. 36A shows an initial position of the constriction elements wherethe wall portion is not constricted by the constriction elements and theelectrical elements 7 are not energized.

FIG. 36B shows how the control device 4 controls the constrictionelements to swing the left ends of the constriction elements toward thewall portion (indicated by arrows) to constrict the tubular wallportion, while energizing the electrical elements, so that theelectrical elements that contact the wall portion 8 contract the latter.

FIG. 36 C shows how the intestinal passageway of the tubular wallportion is completely closed by the thickened wall portion.

FIG. 36D shows how the control device controls the constriction elementsto move so that their right ends are moving towards each other(indicated by arrows), while the convex surfaces of the constrictionelements are rolling on each other with the contracted wall portionbetween them. As a result, the bodily matter in the intestinalpassageway of the intestines is forced to the right (indicated by awhite arrow).

FIG. 36E shows how when the constriction elements have rolled on eachother to the position, the control device controls the right ends of theconstriction elements to move away from each other to the initialposition shown in FIG. 36A.

FIGS. 37 to 49 are schematic block diagrams illustrating twelveembodiments, respectively, of an apparatus used for practicing themethod of the invention, wherein wireless energy is transmitted fromoutside a patient's body to energy consuming components of the apparatusimplanted in the patient.

FIG. 37 schematically shows a general embodiment of the apparatus of theinvention, in which energy is transferred to energy consuming componentsof the apparatus implanted in the patient.

FIG. 38 shows a special embodiment of the general embodiment of FIG. 37having some parts implanted in a patient and other parts located outsidethe patients body where all parts placed to the right of the patient'sskin 109 are implanted and all parts placed to the left of the skin 109are located outside the patient's body.

FIG. 39 shows another embodiment of the invention including theenergy-transforming device, the constriction/stimulation unit and anoperation device in the form of a motor for operating the constrictiondevice of the constriction/stimulation unit.

FIG. 40 shows yet another embodiment of the invention including theenergy transforming device, the constriction/stimulation unit and anassembly including a motor/pump unit and a fluid reservoir.

FIG. 41 shows an apparatus comprising the external energy-transmissiondevice that controls the control unit to reverse the motor when needed,the constriction/stimulation unit, the constriction device of which ishydraulically operated, and the implanted energy-transforming device,and further comprises an implanted hydraulic fluid reservoir, animplanted motor/pump unit, an implanted reversing device in the form ofa hydraulic valve shifting device and a separate external wirelessremote control.

FIG. 42 shows an embodiment of the invention including theenergy-transforming device and the constriction/stimulation unit.

FIG. 43 shows an embodiment of the invention including theenergy-transforming device, the constriction/stimulation unit.

FIG. 44 shows an apparatus identical to that of FIG. 43, except that acontrol unit also is implanted in the patient.

FIG. 45 shows an apparatus identical to that of FIG. 44, except that theaccumulator is substituted for the battery and the implanted componentsare interconnected differently.

FIG. 46 shows an apparatus identical to that of FIG. 45, except that thebattery 125 also is implanted in the patient and the implantedcomponents are interconnected differently.

FIG. 47 shows an apparatus identical to that of FIG. 43, except that amotor 115, a mechanical reversing device in the form of a gearbox 127and a control unit 122 for controlling the gearbox 127 also areimplanted in the patient.

FIG. 48 shows an apparatus identical to that of FIG. 46 except that theimplanted components are interconnected differently.

FIG. 49 shows an embodiment of the invention identical to that of FIG.39, except that a gearbox that connects the motor to theconstriction/stimulation unit, and a control unit that controls theenergy-transforming device to power the motor also are implanted in thepatient.

FIG. 50 illustrates an energy-transforming device in the form of anelectrical junction element used for practicing the method of theinvention.

FIG. 51 is a block diagram illustrating control components used forpracticing the method of the invention.

FIG. 52 is a schematic view of exemplary circuitry of an embodiment ofthe invention, in which wireless energy is transformed into a current.

FIGS. 53A-53C schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIG. 2 used forpracticing the method of the invention, wherein a constriction deviceand a stimulation device co-operate to move the intestinal contents inthe intestinal passageway of a patient's intestines.

FIGS. 54A-54B schematically illustrate different operation stages ofanother apparatus of the type shown in FIGS. 36A-36E used for practicingthe method of the invention, wherein a constriction device and astimulation device co-operate to move the intestinal contents in theintestinal passageway of a patient's intestines.

FIG. 54A illustrates how the constriction element has started toconstrict the wall of the intestines and how the intestinal passagewayof the intestines is closed with the aid of the electrical elements onthe constriction element, whereas the constriction element is about torelease the intestines.

FIG. 54B illustrates how the constriction element has advanced abouthalfway along the elongate support element and moved the bodily matterin the intestinal passageway in a direction indicated by an arrow.

FIG. 55A is a schematic view of another mechanically operablenon-inflatable constriction device used for practicing the method of theinvention.

FIG. 55B shows the constriction device of FIG. 55A in a constrictedstate.

FIG. 55C is an end view of the embodiment of FIG. 55B.

FIG. 56 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 57 schematically shows an embodiment of the invention, in which theapparatus is operated with wire bound energy.

FIG. 58 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 59 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIG. 60 is a sectional view through a constriction device.

FIG. 61 A-C illustrates the constriction device of FIG. 60 in differentinterrupting stages.

FIG. 61 A illustrates the constriction device of FIG. 60 in a firstinterrupting stage, wherein every other constriction element is in aclosed position

FIG. 61 B illustrates the constriction device of FIG. 60 in a secondinterrupting stage, wherein every constriction element that was closedin the first interrupting stage is in an open position and vice versa.

FIG. 61C illustrates the constriction device of FIG. 60 in a thirdinterrupting stage, wherein every other constriction element is in aclosed position, exactly as in the first interrupting stage.

FIGS. 62 A-D show a second embodiment of a constriction device thatoperates in a way similar to the stages of the first embodiment of aconstriction device shown in FIGS. 61A-C; however, in this embodiment,two consecutive constriction elements are in an open position at a timewhen allowing progress of the fecal matter.

FIGS. 62 A-D show a second embodiment of a constriction device thatoperates in a way similar to the stages of the first embodiment of aconstriction device shown in FIGS. 61A-C; however, in this embodiment,two consecutive constriction elements are in an open position at a timewhen allowing progress of the fecal matter.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1A, 1B and 1C schematically illustrate different states ofoperation of a generally designed apparatus used for practicing themethod of the present invention, when the apparatus is applied on a wallportion of a patient's intestines designated BO. The apparatus includesa constriction device and a stimulation device, which are designatedCSD, and a control device designated CD for controlling the constrictionand stimulation devices CSD. FIG. 1A shows the apparatus in aninactivation state, in which the constriction device does not constrictthe intestines BO and the stimulation device does not stimulate theintestines BO. FIG. 1B shows the apparatus in a constriction state, inwhich the control device CD controls the constriction device to gentlyconstrict the wall portion of the intestines BO to a constricted state,in which the blood circulation in the constricted wall portion issubstantially unrestricted and the flow in the intestinal passageway ofthe wall portion is restricted. FIG. 1C shows the apparatus in astimulation state, in which the control device CD controls thestimulation device to stimulate different areas of the constricted wallportion, so that the wall portion of the intestines BO contracts(thickens) and closes the intestinal passageway.

FIGS. 1D and 1E show how the stimulation of the constricted wall portioncan be cyclically varied between a first stimulation mode, in which theleft area of the wall portion (see FIG. 1D) is stimulated while theright area of the wall portion is not stimulated, and a secondstimulation mode, in which the right area of the wall portion (see FIG.1E) is stimulated while the left area of the wall portion is notstimulated, in order to maintain over time satisfactory bloodcirculation in the constricted wall portion.

It should be noted that the stimulation modes shown in FIGS. 1D and 1Eonly constitute a principle example of how the constricted wall portionof the intestines BO may be stimulated. Thus, more than two differentareas of the constricted wall portion may be simultaneously stimulatedin cycles or successively stimulated. Also, groups of different areas ofthe constricted wall portion may be successively stimulated.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment shown in FIGS. 1A-1E, wherein theconstriction and stimulation devices CSD include several separateconstriction/stimulation elements, here three elements CSDE1, CSDE2 andCSDE3. FIG. 1F shows how the element CSDE1 in a first state of operationis activated to both constrict and stimulate the intestines BO, so thatthe intestinal passageway of the intestines BO is closed, whereas theother two elements CSDE2 and CSDE3 are inactivated. FIG. 1G shows howthe element CSDE2 in a second following state of operation is activated,so that the intestinal passageway of the intestines BO is closed,whereas the other two elements CSDE1 and CSDE3 are inactivated. FIG. 1Hshows how the element CSDE3 in a following third state of operation isactivated, so that the intestinal passageway of the intestines BO isclosed, whereas the other two elements CSDE1 and CSDE2 are inactivated.By shifting between the first, second and third states of operation,either randomly or in accordance with a predetermined sequence,different portions of the intestines can by temporarily constricted andstimulated while maintaining the intestinal passageway of the intestinesclosed, whereby the risk of injuring the intestines is minimized. It isalso possible to activate the elements CSDE1-CSDE3 successively alongthe intestinal passageway of the intestines to move intestinal contentsin the intestinal passageway.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment. Thus, FIG. 1I shows how theelement CSDE1 in a first state of operation is activated to bothconstrict and stimulate the intestines BO, so that the intestinalpassageway of the intestines BO is closed, whereas the other twoelements CSDE2 and CSDE3 are activated to constrict but not stimulatethe intestines BO, so that the intestinal passageway of the intestinesBO is not completely closed where the elements CSDE2 and CSDE3 engagethe intestines BO. FIG. 1K shows how the element CSDE2 in a secondfollowing state of operation is activated to both constrict andstimulate the intestines BO, so that the intestinal passageway of theintestines BO is closed, whereas the other two elements CSDE1 and CSDE3are activated to constrict but not stimulate the intestines BO, so thatthe intestinal passageway of the intestines BO is not completely closedwhere the elements CSDE1 and CSDE3 engage the intestines BO. FIG. 1Lshows how the element CSDE3 in a following third state of operation isactivated to both constrict and stimulate the intestines BO, so that theintestinal passageway of the intestines BO is closed, whereas the othertwo elements CSDE1 and CSDE2 are activated to constrict but notstimulate the intestines BO, so that the intestinal passageway of theintestines BO is not completely closed where the elements CSDE1 andCSDE2 engage the intestines BO. By shifting between the first, secondand third states of operation, either randomly or in accordance with apredetermined sequence, different portions of the intestines can bytemporarily stimulated while maintaining the intestinal passageway ofthe intestines closed, whereby the risk of injuring the intestines isreduced. It is also possible to activate the stimulation of the elementsCSDE1-CSDE3 successively along the intestinal passageway of theintestines BO to move intestinal contents in the intestinal passageway.

FIGS. 2-4 show basic components of an embodiment of the apparatusaccording to FIGS. 1A-1C for controlling a flow of intestinal contentsin the intestinal passageway of a patient's intestines formed by atissue wall of a patient's intestines. The apparatus includes a tubularhousing 1 with open ends, a constriction device 2 arranged in thehousing 1, a stimulation device 3 integrated in the constriction device2, and a control device 4 (indicated in FIG. 4) for controlling theconstriction and stimulation devices 2 and 3. The constriction device 2has two elongate clamping elements 5, 6, which are radially movable inthe tubular housing 1 towards and away from each other between retractedpositions, see FIG. 3, and clamping positions, see FIG. 4. Thestimulation device 3 includes a multiplicity of electrical elements 7positioned on the clamping elements 5, 6, so that the electricalelements 7 on one of the clamping elements 5, 6 face the electricalelements 7 on the other clamping element. Thus, in this embodiment theconstriction and stimulation devices form a constriction/stimulationunit, in which the constriction and stimulation devices are integratedin a single piece.

The constriction and stimulation devices may also be separate from eachother. In this case, a structure may be provided for holding theelectrical elements 7 in a fixed orientation relative to one another.Alternatively, the electrical elements 7 may include electrodes that areseparately attached to the wall portion of the patient's intestines.

FIGS. 5A-5C illustrate in principle the function of the apparatus ofFIG. 2 when the apparatus is applied on a portion 8 of a tubular tissuewall of a patient's intestines. Thus, FIG. 5A shows the apparatus in anon-clamping state, in which the clamping elements 5, 6 are in theirretracted positions and the wall portion 8 extends through the open endsof the housing 1 without being constricted by the clamping elements 5,6. FIG. 5B shows the apparatus in a clamping state, in which theclamping elements 5, 6 have been moved from their retracted positions totheir clamping positions, in which the clamping elements 5, 6 gentlyconstrict the wall portion 8 to a constricted state, in which the bloodcirculation in the constricted wall portion 8 is substantiallyunrestricted and the flow in the intestinal passageway of the wallportion 8 is restricted. FIG. 5C shows the apparatus in a stimulationstate, in which the clamping elements 5, 6 constrict the wall portion 8and the electrical elements 7 of the stimulation device 3 electricallystimulate different areas of the wall portion 8, so that the wallportion 8 contracts (thickens) and closes the intestinal passageway.

When the apparatus is in its stimulation state, it is important tostimulate the different areas of the wall portion 8 in a manner so thatthey essentially maintains their natural physical properties over timeto prevent the areas from being injured. Consequently, the controldevice 4 controls the stimulation device 3 to intermittently stimulateeach area of the wall portion 8 during successive time periods, whereineach time period is short enough to maintain over time satisfactoryblood circulation in the area. Furthermore, the control device 4controls the stimulation of the areas of the wall portion 8, so thateach area that currently is not stimulated restores substantially normalblood circulation before it is stimulated again. To maintain over timethe effect of stimulation, i.e., to keep the intestinal passagewayclosed by maintaining the wall portion 8 contracted, the control device4 controls the stimulation device 3 to stimulate one or more of theareas at a time and to shift the stimulation from one area to anotherover time. The control device 4 may control the stimulation device 3 tocyclically propagate the stimulation of the areas along the tubular wallportion 8, for example in accordance with a determined stimulationpattern. To achieve the desired reaction of the tissue wall during thestimulation thereof, the control device may control the stimulationdevice to, preferably cyclically, vary the intensity of the stimulationof the wall portion 8.

In the embodiment of FIGS. 2-4, the electrical elements 7 form a seriesof fourteen groups of electrical elements 7 extending longitudinallyalong each elongate clamping element 5 and 6, respectively, see FIG. 2.The electrical elements 7 of each group of electrical elements 7 form afirst path of four electrical elements 7 positioned in a row on clampingelement 5 and extending tranverse thereto and a second path of fourelectrical elements 7 positioned in a row on clamping element 6 andextending tranverse thereto. Thus, the two paths of electrical elements7 extend on mutual sides of the patient's intestines. The control device4 controls the stimulation device 3 to successively energize the groupsof electrical elements 7 in the series of groups in a direction oppositeto or, alternatively, in the same direction as that of the flow in thepatient's intestinal passageway. Of course, the number of electricalelements 7 of each path of electrical elements 7 can be greater orsmaller than four, and several parallel rows electrical elements 7 canform each path of electrical elements 7.

FIGS. 6A-6C show another embodiment of an apparatus used for practicingthe method of the invention including a tubular housing 9 and threeelongate clamping elements 10 a, 10 b, 10 c, which are radially movablein the tubular housing 9 towards and away from a central axis thereofbetween retracted positions, see FIG. 6A, and clamping positions, seeFIG. 6B. The three clamping elements 10 a-10 c are symmetricallydisposed around the central axis of the housing 9. The stimulationdevice of this embodiment includes electrical elements 11 a, 11 b, 11 cthat form a series of groups of elements extending longitudinally alongthe elongate clamping elements 10 a-10 c, wherein the electricalelements 11 a-11 c of each group of electrical elements form a path ofthree electrical elements 11 a, 11 b and 11 c extendingcircumferentially around the central axis of the housing 9. The threeelectrical elements 11 a-11 c of each group are positioned on the threeclamping elements 10 a-10 c, respectively. Thus, the path of threeelectrical elements 11 a-11 c extends around the patient's intestines.Of course, the number of electrical elements 11 a-11 c of each path ofelectrical elements can be greater than three, and several parallel rowselectrical elements 11 a-11 c can form each path of electrical elements.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the clamping elements 5, 6 ofthe apparatus are constricting a portion of a tubular tissue wall of apatient's intestines 12 to restrict the flow in the intestinalpassageway 13 of the intestines 12. For the sake of clarity only theclamping elements 5, 6 of the constriction device 2 are shown in FIGS.7A, 7B. Thus, FIG. 7A illustrates how energized electrical elements 7 ofgroups of electrical elements electrically stimulate a first portion 14and a second portion 15 of the tubular wall to contract and close theintestinal passageway 13. FIG. 7B illustrates how energized electricalelements 7 of other groups of electrical elements electrically stimulatea third portion 16 of the tubular wall different from the first andsecond portions to contract and close the intestinal passageway 13,while the electrical stimulation of the first and second portions 14, 15of the tubular wall has been ceased, so that substantially normal bloodcirculation in the first and second portions is restored. In thismanner, the electric stimulation of the constricted tubular wall isshifted over time from one portion of the tubular wall to another toinsure recurrent restoration of blood circulation in the constrictedtubular wall.

The control device 4 controls the stimulation device 3 to energize theelectrical elements 7 with electric biphasic pulses, i.e., combinedpositive and negative pulses. The desired stimulation effect is achievedby varying different pulse parameters. Thus, the control device 4controls the stimulation device 3 to vary the pulse amplitude (voltage),the off time period between successive pulses, the pulse duration andthe pulse repetition frequency. The pulse current should be between 1 to30 mA. For neural stimulation, a pulse current of about 5 mA and a pulseduration of about 300 μs are suitable, whereas a pulse current of about20 mA and a pulse duration of about 30 μs are suitable for muscularstimulation. The pulse repetition frequency suitably is about 10 Hz. Forexample, as illustrated in the Pulse/time diagram P/t of FIG. 8A, apulse combination including a negative pulse PS of short duration andhigh amplitude (voltage), and a positive pulse PL of long duration andlow amplitude following the negative pulse may be cyclically repeated toform a pulse train of such pulse combinations. The energy content of thenegative pulse PS should be substantially equal to the energy content ofthe positive pulse PL.

FIG. 8B is a pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A. Thus, the pulse combination of FIG. 8A ismixed with a pulse train combination having a first relatively longpulse train PTL of high frequency/low amplitude pulses, appearingsimultaneously with the positive pulse PL of the pulse combination ofFIG. 8A, and a second relatively short pulse train PTS of highfrequency/low amplitude appearing simultaneously with the negative pulsePS of the pulse combination shown in FIG. 8A. As a result, the highfrequency/low amplitudes pulse trains PTL and PTS are superimposed onthe positive and negative pulses PL and PS of FIG. 8A, as illustrated inFIG. 8B. The pulse configuration of FIG. 8B, and variations thereof, isbeneficial to use in connection with the stimulation of particular humanintestines, in order to achieve the desired stimulation effect.

Preferably, the electric pulses form pulse trains, as illustrated in thePulse/time diagrams P/t of FIGS. 9A, 9B, 9C and 9D. The Pulse/timediagram P/t of FIG. 9A represents an individual area of the wall portionof the patient's tubular intestines which is stimulated with a pulsetrain 18A. The pulse train 18A includes three initial negative pulses,each of which is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the negativepulses. After a delay to enable the area of the intestines to restoresubstantially normal blood circulation the pulse train 18A is repeated.

The Pulse/time diagram P/t of FIG. 9B represents another individual areaof the wall portion, which is stimulated with a pulse train 18B havingthe same configuration as the pulse train 18A. The pulse trains 18A and18B are shifted relative to each other, so that they partially overlapone another to ensure that the constricted wall portion always isstimulated to contract as desired.

The pulse/time diagrams P/t of FIGS. 10A and 10B represent two differentareas of the wall portion, which are stimulated with cyclically repeatedpulse trains 18C and 18D, respectively, having the same configuration.Each pulse train 18C, 18D includes two initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the twonegative pulses. In this case, the pulse trains 18C and 18D are shiftedrelative to each other, so that they do not overlap each other. Thus,the off time period between adjacent pulse trains 18C is longer than theduration of pulse train 18D and the off time period between adjacentpulse trains 18D is longer than the duration of pulse train 18C.

The pulse trains 18A, 18B, 18C and 18D can be configured in manydifferent ways. Thus, the control device 4 can control the stimulationdevice 2 to vary the length of each pulse train, the repetitionfrequency of the pulse trains, the number of pulses of each pulse train,and/or the off time periods between the pulse trains. Typically, thecontrol device 4 controls each off time period between the pulse trainsto last long enough to restore substantially normal blood circulation inthe area that just has been stimulated before that area again isstimulated with electric pulses.

FIGS. 11A and 11B show another embodiment of an apparatus used forpracticing the method of the invention that controls blood flow in ablood vessel 19. The apparatus of FIGS. 11A and 11B includes aconstriction device with two clamping elements 20 a and 20 b, astimulation device in the form of two thermal stimulation elements 21 aand 21 b integrated in the clamping elements 20 a, 20 b, respectively,and a control device 4 for controlling the clamping elements 20 a, 20 band stimulation elements 21 a, 21 b. The clamping elements 20 a and 20 bare movable towards and away from each other in the same manner asdescribed above in connection with the embodiment according to FIGS.5A-5C. The thermal stimulation elements 21 a and 21 b, which may includePertier elements, are positioned on the clamping elements 20 a, 20 b, sothat the thermal elements 21 a are facing the thermal elements 21 b.FIG. 11A shows how the clamping elements 20 a, 20 b constrict the bloodvessel 19, so that the blood flow is restricted. FIG. 11B shows how thecontrol device 4 controls the thermal stimulation elements 21 a, 21 b tocool the wall of the blood vessel 19, so that the wall contracts andcloses the blood vessel 19. To release the blood vessel 19, the controldevice 4 controls the thermal stimulation elements 21 a, 21 b to heatthe wall of the blood vessel 19, so that the wall expands.

FIGS. 12A and 12B show hydraulic operation means suited for operatingthe constriction device of the embodiments described above.Specifically, FIGS. 12A and 12B show the apparatus of FIG. 2 providedwith such means for hydraulic operation of the constriction device 2.(The stimulation device is not shown.) Thus, the housing 1 forms twohydraulic chambers 22 a and 22 b, in which the two clamping elements 5,6are slidable back and forth relative to the tubular tissue wall portion8 of a patient's intestines. The hydraulic operation means include anexpandable reservoir 23, such as an elastic balloon, containinghydraulic fluid, conduits 24 a and 24 b between the reservoir 23 and thehydraulic chambers 22 a, 22 b, and a two-way pump 25 for pumping thehydraulic fluid in the conduits 24 a, 24 b. The control device 4controls the pump 25 to pump hydraulic fluid from the reservoir 23 tothe chambers 22 a, 22 b to move the clamping elements 5, 6 against thewall portion 8, whereby the tubular wall portion 8 is constricted, seeFIG. 12B, and to pump hydraulic fluid from the chambers 22 a, 22 b tothe reservoir 23 to move the clamping elements 5, 6 away from the wallportion 8, whereby the tubular wall 8 is released, see FIG. 12A.

Alternatively, the embodiment of FIGS. 12A and 12B may be manuallyoperated by applying suitable manually operable hydraulic means fordistributing the hydraulic fluid between the expandable reservoir 23 andthe hydraulic chambers 22 a, 22 b. In this case the pump 25 is omitted.

FIGS. 13A and 13B schematically show another embodiment of an apparatusused for practicing the method of the invention. The apparatus of FIGS.13A and 13B comprises an open ended tubular housing 26 applied on thetubular tissue wall portion 8 of a patient's intestines, a constrictiondevice 27 arranged in the housing 26 and a control device 4 forcontrolling the constriction device 27. A stimulation device (not shown)as described above is also provided in the housing 26. The constrictiondevice 27 includes a clamping element 28, which is radially movable inthe tubular housing 26 towards and away from the tubular wall portion 8between a retracted position, see FIG. 13A, and a clamping position, seeFIG. 13B, in which the clamping element 28 gently constricts the tubularwall portion 8. Mechanical operation means for mechanically operatingthe clamping element 28 includes an electric motor 29 attached to thehousing 26 and a telescopic device 30, which is driven by the motor 29and operatively connected to the clamping element 28. The control device4 controls the electric motor 29 to expand the telescopic device 30 tomove the clamping element 28 against the wall portion 8, whereby thetubular wall portion 8 is constricted, see FIG. 13B, and controls themotor 29 to retract the telescopic device 30 to move the clampingelement 28 away from the wall portion 8, whereby the wall portion 8 isreleased, see FIG. 13A.

Alternatively, the motor 29 may be omitted and the telescopic device 30be modified for manual operation, as shown in FIG. 13C. Thus, a spring30 a may be provided acting to keep the telescopic device 30 expanded toforce the clamping element 28 against the wall portion 8. The mechanicaloperation means may include a subcutaneously implanted lever mechanism29 a that is operatively connected to the telescopic device 30. Thepatient may push the lever mechanism 29 a through the skin to pull thetelescopic device 30 against the action of the spring 30 a to theretracted position of the telescopic device 30, as indicated in phantomlines. When the patient releases the lever mechanism 29 a, the spring 30a expands the telescopic device 30, whereby clamping element 28 isforced against the wall portion 8.

The mechanical operation means as described above in connection withFIGS. 13A, 13B and 13C may also be implemented in the embodimentsaccording to FIGS. 1-11.

FIG. 14A illustrates the apparatus of FIG. 2 applied on the intestines31 of a colostomy patient having a stoma in the abdomen. The clampingelements 5, 6 of the constriction device 2 constrict the intestines 31and the stimulation device 3 is energized to close the intestinalpassageway. (For the sake of clarity, the housing is not shown and theclamping elements 5, 6 are exaggerated.) In this embodiment, a controldevice includes an external control unit in the form of a hand-heldwireless remote control 32, and an implanted internal control unit 33,which may include a microprocessor, for controlling the constriction andstimulation devices. The remote control 32 is operable by the patient tocontrol the internal control unit 33 to switch on and off theconstriction device and/or the stimulation device. Alternatively,however, the remote control 32 may be replaced by a subcutaneouslyimplanted push button that is manually switched by the patient between“on” and“off”. Such a manually operable push button may also be providedin combination with the remote control 32 as an emergency button toallow the patient to stop the operation of the apparatus in case ofemergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the intestines, or a parameter that relates to thepressure in the intestines, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's intestines 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's intestines 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36. The remote control 32 may be equipped with means forproducing an indication, such as a sound signal or displayedinformation, in response to signals from the sensor 36, in the samemanner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, he or she may use the remote control to control theconstriction device and stimulation device to pump feces through thepatient's stoma.

FIG. 14B shows an embodiment which is similar to the embodiment of FIG.14A except that the constriction device is applied on the smallintestines of a patient having the small intestines surgically connectedto the patient's anus.

FIGS. 15-17 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 15-17 includes amechanically operable constriction device having an elongatedconstriction member in the form of a circular resilient core 37 with twooverlapping end portions 38,39. The core 37 defines a substantiallycircular restriction opening and is enclosed in an elastic soft hose 40except at a releasable and lockable joint 41 of the core 37, which whenreleased enables application of the core 37 with its hose 40 around aportion of a tubular tissue wall of a patient. The materials of all ofthese elements are bio-compatible so that the patient' body will notreject them. An operation device 42 for mechanically operating thelongitudinal extension of the core 37 to change the size of therestriction opening comprises a drive wheel 43 in frictional engagementwith the overlapping end portions 38,39 of the core 37. The drive wheel43 is journalled on a holder 44 placed in the hose 40 and provided withtwo counter pressure rollers 45,46 pressing the respective end portions38, 39 of the core 37 against the drive wheel 43 to increase thefrictional engagement there between. An electric motor 47 of theoperation device is connected to the drive wheel 43 via a long flexibledrive shaft 48 and is moulded together with a remote controlled powersupply unit 49 in a body 50 of silicone rubber. The length of theflexible drive shaft 48 is selected so that the body 50 can be placed ina desired position in the patient's body, suitably in the abdomen.

The power supply unit 49 can be controlled to power the electric motor47 to turn the drive wheel 43 in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or to turn thedrive wheel 43 in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

In accordance with a first alternative, a rack gear may be formed on oneof the end portions 38,39 of the core 37 and the drive wheel 43 may bereplaced by a drive gear wheel connected to the other end portion of thecore 37 and in mesh with the rack gear.

In accordance with a second alternative, the operation device 42 may bedesigned as a worm-driven hose clamp, i. e., one of the end portions 38,39 of the core 37 may be provided with threads and the other end portionof the core 37 may be provided with a worm, the threads of whichinteracts with the threads of said one end portion of the core 37. Thethreads of such a worm may also interact with threads provided on bothend portions 38, 39 of the core 37. In this alternative, the electricmotor 47 turns the worm in one direction to reduce the diameter of thecore 37, so that the wall portion is constricted, or turn the worm inthe opposite direction to increase the diameter of the core 37, so thatthe wall portion is released in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or turns theclamping screw in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

FIG. 18 shows a constriction device which is identical to theconstriction device shown in FIGS. 15-17, except that the motor 47 isencapsulated in the hose 40 so that it is fixed to the core 37 and has ashort drive shaft 51, and that the motor 47 is positioned relative tothe core 37 such that the drive shaft 51 extends substantiallytangentially to the circular core 37. There is an angular gearing 52connecting the drive shaft 51 to the drive wheel 43.

FIG. 19 shows a suitable alternative arrangement for the motor 47 in theembodiment of FIG. 17, comprising a first clamping member 53 secured toone end portion of the core 37 and a second clamping member 54 securedto the other end portion 39 of the core 37. The motor 47 is secured tothe first clamping member 53 and is operatively connected to a worm 55via a gear transmission 56. The worm 55 is journalled at its oppositeends on holders 57 and 58, which are rigidly secured to the clampingmember 53 and the motor 47, respectively. The second clamping member 54has a pinion in mesh with the worm 55. When the motor 47 is powered theworm 55 rotates and will thereby pull the end portion 39 of the core 37in one or the opposite longitudinal direction, so that the diameter ofthe substantially circular core 37 is either increased or decreased. Themotor 47, worm gear 55, gear transmission 56 and second clamping member54 constitute a servo system of the type that transfers a weak forceacting on a moving element having a long stroke into a strong forceacting on another moving element having a short stroke.

FIG. 20 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 20 includes aconstriction device having a plurality of arcuate lamellae 59 arrangedlike the conventional adjustable aperture mechanism of a camera. A motor60 operates the lamellae 59 to change the size of a restriction openingdefined by the lamellae 59.

FIGS. 21-23 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 21-23 includes aconstriction device having two semi-circular elements 61 and 62, whichare hinged together. The semi-circular elements 61,62 are swingablerelative to each other between a fully open state in which theysubstantially form a circle, illustrated in FIG. 23 and an angularstate, in which the size of the restriction opening defined by thesemi-circular elements 61, 62 is reduced, illustrated in FIG. 24. Amotor 63 operates the semi-circular elements 61, 62 to swing themrelative to each other.

FIGS. 24-28 show another embodiment of an apparatus used for practicingthe method of the invention. The apparatus of FIGS. 24-28 includes aconstriction device having an elastic belt 64, which forms a circle andhas a substantially oval cross-section. A motor 67 operates the belt 64to turn around the longitudinal extension thereof between a fully openstate, in which the inner broader side of the belt 64 forms asubstantially cylindrical surface, illustrated in FIG. 25, and a reducedopen state, in which the inner broader side of the belt 64 forms asubstantially conical surface, illustrated in FIG. 26.

FIG. 27 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 27 includes aconstriction device 68 having two rigid articulated clamping elements 69positioned on opposite sides of a portion of a tubular tissue wall 70 ofa patient. An operation device 71 turns the clamping elements 69 towardeach other to clamp the wall portion 70 between the clamping elements 69to thereby contract the wall portion, and turns the clamping elements 69away from each other to release the wall portion from the clampingelements 69.

FIGS. 28 and 29 show another embodiment of an apparatus used forpracticing the method of the invention. The apparatus of FIGS. 28 and 29include a constriction device 300 having three bending members 301, 302and 303 displaced relative to one another in a row along a portion of atubular tissue wall 304 of a patient's intestines and positionedalternately on opposite sides of the tubular wall 304. (Alternatively,each member 301, 302 and 303 may take the shape of an hour-glass.) Anoperation device (not shown) moves the two outer members 301, 303laterally against the tubular wall 304 in one direction and theintermediate member 302 against the tubular wall 304 in the oppositedirection to bend the tubular wall 304 to thereby constrict the tubularwall portion 304, see FIG. 29. To release the wall portion 304 theoperation device moves the members 301-303 away from the tubular wallportion 304 to the position shown in FIG. 28.

FIGS. 30A and 30B show another embodiment of an apparatus used forpracticing the method of the invention. The apparatus of FIGS. 30A and30B include a hydraulically operable elongated constriction device inthe form of a band 72 having an expandable/contractible cavity 73, whichis in fluid communication with an adjustable reservoir 74 containinghydraulic fluid. FIG. 30A illustrates when the band is in anon-constriction state, whereas FIG. 30B illustrates when the band is ina constriction state, in which the cavity 73 is expanded by hydraulicfluid supplied by the reservoir 74.

FIGS. 31A, 31B, 31C and 31D are block diagrams of three differentlyoperated hydraulic constriction devices used for practicing the methodof the invention. FIG. 31A shows the band 72 of FIG. 30A, the cavity 73of which is in fluid communication with a reservoir 75. FIG. 31B showsthe embodiment of FIG. 30A, in which the cavity 73 of the band 72 is influid communication with the reservoir 74 via an operation device in theform of a two-way pump 76. FIG. 31C shows an operation device in theform of a reverse servo system with a first closed system controlling asecond system. The reverse servo system comprises an adjustable fluidsupply reservoir 77 and an adjustable servo reservoir 78. The servoreservoir 78 controls a larger adjustable reservoir 79 which inconnection with the band 72 applied around a portion of tubular tissuewall of a patient's intestines varies the volume of the cavity 73 of theband 72, which in turn varies the constriction of the wall portion. FIG.31D shows an embodiment identical to the embodiment of FIG. 31C, exceptthat the larger reservoir 79 is omitted. Instead, the servo reservoir 78is in fluid communication with the cavity of the band 72.

In all of the above embodiments according to FIGS. 12A through 30B,stimulation devices may be provided to form constriction/stimulationunits, in which the stimulation devices include a multiplicity ofelectrical elements 7 (indicated in FIGS. 12A-15, 18, 20-23, 26-31B)positioned on the constriction devices.

FIG. 32 is a cross-sectional view of a fluid supply device including abellows reservoir 80 defining a chamber 81, the size of which isvariable by an operation device comprising a remote controlled electricmotor 82. The reservoir 80 and the motor 82 are placed in a housing 83.Moving a large wall 84 varies the chamber 81. The wall 84 is secured toa nut 85, which is threaded on a rotatable spindle 86. The spindle 86 isrotated by the motor 82. A battery 89 placed in the housing 83 powersthe motor 82. A signal receiver 90 for controlling the motor 82 is alsoplaced in the housing 83. Alternatively, the battery 89 and the signalreceiver 90 may be mounted in a separate place. The motor 82 may also bepowered with energy transferred from transmitted signals.

Where applicable, the fluid supply device of FIG. 32 may be used forsupplying hydraulic fluid for the operation of the constriction devicesdescribed in this specification. For example, the fluid supply device ofFIG. 32 may be substituted for the reservoir 74 in the embodimentaccording to FIG. 30A.

FIGS. 33A and 33B show a reverse servo used for practicing the method ofthe invention. The reverse servo includes a rectangular housing 91 andan intermediate wall 92, which is movable in the housing 91. Arelatively large, substantially cylindrical bellows reservoir 93 isarranged in the housing 91 and is joined to the movable intermediatewall 92. Another cylindrical bellows reservoir 94, which issubstantially smaller than reservoir 93, is arranged in the housing 91at the other side of the intermediate wall 92 and is also joined to thewall 92. The small bellows reservoir 94 has a fluid supply pipe 95 andthe large bellows reservoir 93 has a fluid supply pipe 96.

Referring to FIG. 33A, when a small amount of hydraulic fluid isconducted through the supply pipe 95 into the small bellows reservoir94, the small bellows reservoir 94 expands and pushes the movableintermediate wall 92 towards the large bellows reservoir 93. As aresult, the large bellows reservoir 93 is contracted by the intermediatewall 92, whereby a large amount of hydraulic fluid is forced out of thelarge bellows reservoir 93 through the supply pipe 96, see FIG. 33B.

For example, the reverse servo of FIGS. 33A and 33B may be used in theembodiment of FIG. 31c , wherein the small bellows reservoir 94corresponds to the small servo reservoir 78 and the large bellowsreservoir 93 corresponds to the large reservoir 79. Also, the reverseservo of FIGS. 33A and 33B may be used in the embodiment of FIGS. 30Aand 30B, wherein the small bellows reservoir 94 is connected to theadjustable reservoir 74 and the large bellows reservoir 93 is connectedto the cavity 73 of the band 72.

FIG. 34 schematically shows a hydraulically operable constriction device97, which is similar to the embodiment shown in FIG. 30A, except thatthe hydraulic system is designed differently. Thus, the constrictiondevice 97 includes a relatively small inflatable cavity 98, which is influid communication with a reservoir 99 containing hydraulic fluid, anda relatively large cavity 100, which is displaceable by small cavity 98.Small cavity 98 is adapted to displace large cavity 100 to constrict thepatient's tubular wall portion when small cavity 98 is inflated and todisplace large cavity 100 to release the wall portion when small cavity98 is deflated. Thus, a relatively small addition of hydraulic fluidfrom reservoir 99 to small cavity 98 causes a relatively large increasein the constriction of the wall portion.

Large cavity 100 is defined by a contraction element in the form of abig balloon 101, which may be connected to an injection port (not shown)for calibration of the volume of large cavity 100. Adding fluid to orwithdrawing fluid from the injection port with the aid of a syringecalibrates the volume of balloon 101. Small cavity 98 is defined by asmall bellows 102 attached to an annular frame 103 of constrictiondevice 97 and at the opposite end is attached to balloon 101.

FIGS. 35A and 35B schematically illustrate the operation of constrictiondevice 97, when annular frame 103 is applied around the tubular wallportion of the patient's intestines. Referring to FIG. 35A, when smallcavity 98 is deflated bellows 102 pulls balloon 101 inwardly intoannular frame 103, so that constriction device 97 constricts the wallportion. Referring to FIG. 34B, when small cavity 98 is inflated bellows102 pulls balloon 101 out of annular frame 103, so that constrictiondevice 97 releases the wall portion.

As mentioned above, the constriction device and stimulation device canco-operate to actively move the intestinal contents in the intestinalpassageway of a patient's intestines. This can be practised by use ofthe constriction/stimulation unit according to FIG. 2. Thus, inaccordance with a first cooperation option, the clamping elements 5, 6of the constriction device constricts the wall portion 8 withoutcompletely closing the intestinal passageway, and the control device 4controls the electrical elements 7 to progressively stimulate theconstricted wall portion in the downstream or upstream direction of theintestinal passageway to cause progressive contraction of the wallportion 8 to move the intestinal contents in the intestinal passageway.

In accordance with a second cooperation option, the constriction deviceconstricts the wall portion so that the flow in the intestinalpassageway is restricted, and the control device 4 controls a fewelectrical elements 7 at one end of the elongate clamping elements 5, 6to stimulate the constricted wall portion 8 to close the intestinalpassageway either at an upstream end or a downstream end of the wallportion 8. With the intestinal passageway closed in this manner, thecontrol device 4 controls the constriction device to increase theconstriction of the wall portion, whereby the intestinal contents in theintestinal passageway is moved downstream or upstream of the wallportion 8.

Alternatively, the control device 4 controls the stimulation device tostimulate the constricted wall portion 8 while the constriction devicevaries the constriction of the different areas of the wall portion, sothat the wall portion 8 is progressively constricted in the downstreamor upstream direction of the intestinal passageway. FIGS. 36A-36E showdifferent operation stages of such an alternative embodiment. Thus, aconstriction device 104 used for practicing the method of the inventionincludes two elongate constriction elements 105, 106 having convexsurfaces 107, 108 that abut a length of the wall portion 8 on mutualsides thereof. A multiplicity of electrical elements 7 (such aselectrodes) are positioned on the convex surfaces 107, 108. The controldevice 4 controls the electrical elements 7 during operation of theconstriction device 104 to stimulate the wall portion 8 and controls theelongate constriction elements 105, 106 to move relative to the tubularwall portion 8 so that the constriction elements 105, 106 progressivelyconstrict the wall portion 8, as appears from FIGS. 36A to 36D.

Thus, in an initial position of the constriction elements 105, 106 shownin FIG. 36A, the wall portion is not constricted by the constrictionelements 105, 106 and the electrical elements 7 are not energized.Starting from this initial position, the control device 4 controls theconstriction elements 105, 106 to swing the left ends of theconstriction elements 105, 106 toward the wall portion (indicated byarrows) to constrict the tubular wall portion 8, see FIG. 36B, whileenergizing the electrical elements 7, so that the electrical elements 7that contact the wall portion 8 contract the latter. FIG. 36 C shows howthe intestinal passageway of the tubular wall portion 8 is completelyclosed by the thickened wall portion 8. Then, as shown in FIG. 36C, thecontrol device 4 controls the constriction elements 105, 106 to move sothat their right ends are moving towards each other (indicated byarrows), while the convex surfaces 107, 108 of the constriction elements105, 106 are rolling on each other with the contracted wall portion 8between them, see FIG. 36D. As a result, the bodily matter in theintestinal passageway of the intestines is forced to the right(indicated by a white arrow). When the constriction elements 105, 106have rolled on each other to the position shown in FIG. 36E, the controldevice 4 controls the right ends of the constriction elements 105, 106to move away from each other (indicated by arrows in FIG. 36E) to theinitial position shown in FIG. 36A. The operation stages describedaccording to FIGS. 36A to 36E can be cyclically repeated a number oftimes until the desired amount of bodily matter has been moved in theintestinal passageway of the intestines in a peristaltic manner.

Alternatively, only one of the constriction elements 105, 106 can beprovided with a convex surface, whereas the other constriction elementhas a plane surface that abuts the wall portion. It is also possible touse a single constriction element with a convex surface that presses thetubular portion 8 of the intestines against a bone of the patient.

In the embodiment according to FIGS. 36A to 36E, the control device 4may control the electrical elements 7 to progressively stimulate theconstricted wall portion 8 to cause progressive contraction thereof inharmony with the movement of the elongate constriction elements 105,106, as the convex surfaces 107, 108 of the constriction elements 105,106 are rolling on each other.

FIG. 37 schematically shows a general embodiment of the apparatus of theinvention, in which energy is transferred to energy consuming componentsof the apparatus implanted in the patient.

The apparatus of FIG. 37 comprises an implanted constriction/stimulationunit 109, which is operable to gently constrict a portion of a tubulartissue wall of a patient's intestines and to stimulate different areasof the constricted portion to cause contraction of the wall portion. Theconstriction device of the constriction/stimulation unit 110 is capableof performing a reversible function, i.e., to constrict and release thewall portion, so that the constriction/stimulation unit 110 works as anartificial sphincter.

A source of energy 111 is adapted to supply energy consuming componentsof the constriction/stimulation unit 110 with energy via a power supplyline 112. A wireless remote control or a subcutaneously implanted switchoperable by the patient to switch on or off the supply of energy fromthe source of energy may be provided. The source of energy may be animplantable permanent or rechargeable battery, or be included in anexternal energy-transmission device, which may be operable directly bythe patient or be controlled by a remote control operable by the patientto transmit wireless energy to the energy consuming components of theconstriction/stimulation unit. Alternatively, the source of energy maycomprise a combination of an implantable rechargeable battery, anexternal energy-transmission device and an implantableenergy-transforming device for transforming wireless energy transmittedby the external energy-transmission device into electric energy for thecharge of the implantable rechargeable battery.

FIG. 38 shows a special embodiment of the general embodiment of FIG. 37having some parts implanted in a patient and other parts located outsidethe patient's body. Thus, in FIG. 38 all parts placed to the right ofthe patient's skin 109 are implanted and all parts placed to the left ofthe skin 109 are located outside the patient's body. An implantedenergy-transforming device 111A of the apparatus is adapted to supplyenergy consuming components of the constriction/stimulation unit 110with energy via the power supply line 112. An externalenergy-transmission device 113 of the apparatus includes a wirelessremote control transmitting a wireless signal, which is received by asignal receiver incorporated in the implanted energy-transforming device111A. The implanted energy-transforming device 111A transforms energyfrom the signal into electric energy which is supplied via the powersupply line 112 to the constriction/stimulation unit 110.

The apparatus of FIG. 3 (may also include an implanted rechargeablebattery for energizing energy consuming implanted components of theapparatus. In this case, the implanted energy-transforming device 111Aalso charges the battery with electric energy, as theenergy-transforming device transforms energy from the signal into theelectric energy.

A reversing device in the form of an electric switch 114, such as amicroprocessor, is implanted in the patient for reversing theconstriction device of the constriction/stimulation unit 110. Thewireless remote control of the external energy-transmission device 113transmits a wireless signal that carries energy and the implantedenergy-transforming device 111A transforms the wireless energy into acurrent for operating the switch 114. When the polarity of the currentis shifted by the energy-transforming device 111A the switch 114reverses the function performed by the constriction device of theconstriction/stimulation unit 110.

FIG. 39 shows another embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an operation device in the form of a motor 115 for operating theconstriction device of the constriction/stimulation unit 110. The motor115 is powered with energy from the energy-transforming device 111A, asthe remote control of the external energy-transmission device 113transmits a wireless signal to the receiver of the energy-transformingdevice 111A.

FIG. 40 shows yet another embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an assembly 116 including a motor/pump unit 117 and a fluidreservoir 118. In this case the constriction device of theconstriction/stimulation unit 110 is hydraulically operated, i.e.,hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir118 to the constriction/stimulation unit 110 to constrict the wallportion, and hydraulic fluid is pumped by the motor/pump unit 117 backfrom the constriction/stimulation unit 110 to the reservoir 118 torelease the wall portion. The implanted energy-transforming device 111Atransforms wireless energy into a current, for powering the motor/pumpunit 117.

FIG. 41 shows another embodiment of an apparatus used for practicing themethod of the invention. The apparatus of FIG. 41 comprises the externalenergy-transmission device 113 that controls the control unit 122 toreverse the motor 115 when needed, the constriction/stimulation unit110, the constriction device of which is hydraulically operated, and theimplanted energy-transforming device 111A, and further comprises animplanted hydraulic fluid reservoir 119, an implanted motor/pump unit120, an implanted reversing device in the form of a hydraulic valveshifting device 121 and a separate external wireless remote control111B. The motor of the motor/pump unit 120 is an electric motor. Inresponse to a control signal from the wireless remote control of theexternal energy-transmission device 113, the implantedenergy-transforming device 111A powers the motor/pump unit 120 withenergy from the energy carried by the control signal, whereby themotor/pump unit 120 distributes hydraulic fluid between the reservoir119 and the constriction device of the constriction/stimulation unit110. The remote control 111B controls the shifting device 121 to shiftthe hydraulic fluid flow direction between one direction in which thefluid is pumped by the motor/pump unit 120 from the reservoir 119 to theconstriction device of the constriction/stimulation unit 110 toconstrict the wall portion, and another opposite direction in which thefluid is pumped by the motor/pump unit 120 back from the constrictiondevice of the constriction/stimulation unit 110 to the reservoir 119 torelease the wall portion.

FIG. 42 shows an embodiment of the invention including theenergy-transforming device 111A and the constriction/stimulation unit110. A control unit 122, an accumulator 123 and a capacitor 124 are alsoimplanted in the patient. A separate external wireless remote control111B controls the control unit 122. The control unit 122 controls theenergy-transforming device 111A to store electric energy in theaccumulator 123, which supplies energy to the constriction/stimulationunit 110. In response to a control signal from the wireless remotecontrol 111B, the control unit 122 either releases electric energy fromthe accumulator 123 and transfers the released energy via power lines,or directly transfers electric energy from the energy-transformingdevice 111A via the capacitor 124, which stabilizes the electriccurrent, for the operation of the constriction/stimulation unit 110.

In accordance with one alternative, the capacitor 124 in the apparatusof FIG. 42 may be omitted. In accordance with another alternative, theaccumulator 123 in this apparatus may be omitted.

FIG. 43 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110.A battery 125 for supplying energy for the operation of theconstriction/stimulation unit 110 and an electric switch 126 forswitching the operation of the constriction/stimulation unit 110 arealso implanted in the patient. The switch 126 is operated by the energysupplied by the energy-transforming device 111A to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 44 shows an apparatus identical to that of FIG. 43, except that acontrol unit 122 also is implanted in the patient. A separate externalwireless remote control 111B controls the control unit 122. In thiscase, the switch 126 is operated by the energy supplied by theenergy-transforming device 111A to switch from an off mode, in which thewireless remote control 111B is prevented from controlling the controlunit 122 and the battery 125 is not in use, to a standby mode, in whichthe remote control 111B is permitted to control the control unit 122 torelease electric energy from the battery 125 for the operation of theconstriction/stimulation unit 110.

FIG. 45 shows an apparatus identical to that of FIG. 44, except that theaccumulator 123 is substituted for the battery 125 and the implantedcomponents are interconnected differently. In this case, the accumulator123 stores energy from the energy-transforming device 111A. In responseto a control signal from the wireless remote control 111B, the implantedcontrol unit 122 controls the switch 126 to switch from an off mode, inwhich the accumulator 123 is not in use, to an on mode, in which theaccumulator 123 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 46 shows an apparatus identical to that of FIG. 45, except that thebattery 125 also is implanted in the patient and the implantedcomponents are interconnected differently. In response to a controlsignal from the wireless remote control 111B, the implanted control unit122 controls the accumulator 123, which may be a capacitor, to deliverenergy for operating the switch 126 to switch from an off mode, in whichthe battery 125 is not in use, to an on mode, in which the battery 125supplies electric energy for the operation of theconstriction/stimulation unit 110.

Alternatively, the switch 126 may be operated by energy supplied by theaccumulator 123 to switch from an off mode, in which the wireless remotecontrol 111B is prevented from controlling the battery 125 to supplyelectric energy and the battery 125 is not in use, to a standby mode, inwhich the wireless remote control 111B is permitted to control thebattery 125 to supply electric energy for the operation of theconstriction/stimulation unit 110.

FIG. 47 shows an apparatus identical to that of FIG. 43, except that amotor 115, a mechanical reversing device in the form of a gearbox 127and a control unit 122 for controlling the gearbox 127 also areimplanted in the patient. A separate external wireless remote control111B controls the implanted control unit 122 to control the gearbox 127to reverse the function performed by the constriction device(mechanically operated) of the constriction/stimulation unit 110.

FIG. 48 shows an apparatus identical to that of FIG. 46 except that theimplanted components are interconnected differently. Thus, in this casethe battery 125 powers the control unit 122 when the accumulator 123,suitably a capacitor, activates the switch 126 to switch to an on mode.When the switch 126 is in its on mode the control unit 122 is permittedto control the battery 125 to supply, or not supply, energy for theoperation of the constriction/stimulation unit 110.

FIG. 49 shows an embodiment of the invention identical to that of FIG.39, except that a gearbox 127 that connects the motor 115 to theconstriction/stimulation unit 110, and a control unit 122 that controlsthe energy-transforming device 111A to power the motor 115 also areimplanted in the patient. There is a separate external wireless remotecontrol 111B that controls the control unit 122 to reverse the motor 115when needed.

Optionally, the accumulator 123 shown in FIG. 42 may be provided in theembodiment of FIG. 49, wherein the implanted control unit 122 controlsthe energy-transforming device 111A to store the transformed energy inthe accumulator 123. In response to a control signal from the wirelessremote control 111B, the control unit 122 controls the accumulator 123to supply energy for the operation of the constriction/stimulation unit110.

Any of the apparatuses of FIGS. 36-49 can be used for practicing themethod of the invention.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 38-49 could be combined in many different ways. Forexample, the energy operated switch 114 could be incorporated in any ofthe embodiments of FIGS. 39, 42-49, the hydraulic shifting device 121could be incorporated in the embodiment of FIG. 40, and the gearbox 127could be incorporated in the embodiment of FIG. 39. The switch 114 maybe of a type that includes electronic components, for example amicroprocessor, or a FGPA (Field Programmable Gate Array) designed forswitching. Alternatively, however, the energy operated switch 114 may bereplaced by a subcutaneously implanted push button that is manuallyswitched by the patient between “on” and“off”.

Alternatively, a permanent or rechargeable battery may be substitutedfor the energy-transforming devices 111A of the embodiments shown inFIGS. 38-49.

FIG. 50 shows the energy-transforming device in the form of anelectrical junction element 128 for use in any of the above embodimentsaccording to FIGS. 37-49. The element 128 is a flat p-n junction elementcomprising a p-type semiconductor layer 129 and an n-type semiconductorlayer 130 sandwiched together. A light bulb 131 is electricallyconnected to opposite sides of the element 128 to illustrate how thegenerated current is obtained. The output of current from such a p-njunction element 128 is correlated to the temperature. See the formulabelow.I=I0(exp(qV/kT)−1)

-   -   where    -   I is the external current flow,    -   I0 is the reverse saturation current,    -   q is the fundamental electronic charge of 1.602×10-19    -   coulombs,    -   V is the applied voltage,    -   k is the Boltzmann constant, and    -   T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −I0. I0is strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. I0 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode, that is, its restriction of current flow to onlyone direction, is in this particular embodiment the key to the operationof the p-n junction element 128.

The alternative way to design a p-n junction element is to deposit athin layer of semiconductor onto a supporting material which does notabsorb the kind of energy utilized in the respective embodiments. Foruse with wirelessly transmitted energy in terms of light waves, glasscould be a suitable material. Various materials may be used in thesemiconductor layers such as but not limited to cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 128 could beof the same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating the alternating current.

The p-n junction element 128 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 128 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly depending on temperature as shown above.Since both the skin and subcutis absorb energy, the relation between thesensitivity or working area of the element 128 and the intensity orstrength of the wireless energy-transmission is considered. The p-njunction element 128 preferably is designed flat and small.Alternatively, if the element 128 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 128 should be kept less than 2000 cm3.

FIG. 51 shows basic parts of a remote control used for practicing themethod of the invention. The remote control controls theconstriction/stimulation unit 110. In this case, the stimulation deviceof the constriction/stimulation unit stimulates the wall portion of thepatient's intestines with electric pulses. The remote control is basedon wireless transmission of electromagnetic wave signals, often of highfrequencies in the order of 100 kHz-1 gHz, through the skin 132 of thepatient. In FIG. 51, all parts placed to the left of the skin 132 arelocated outside the patient's body and all parts placed to the right ofthe skin 132 are implanted.

An external signal-transmission device 133 is to be positioned close toa signal-receiving device 134 implanted close to the skin 132. As analternative, the signal-receiving device 134 may be placed for exampleinside the abdomen of the patient. The signal-receiving device 134comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter,wound with a very thin wire and tuned with a capacitor to a specifichigh frequency. A small coil is chosen if it is to be implanted underthe skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The signal transmission device133 comprises a coil having about the same size as the coil of thesignal-receiving device 134 but wound with a thick wire that can handlethe larger currents that is necessary. The coil of the signaltransmission device 133 is tuned to the same specific high frequency asthe coil of the signal-receiving device 134.

The signal-transmission device 133 is adapted to send digitalinformation via the power amplifier and signal-receiving device 134 toan implanted control unit 135. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the signal transmission device 133is used to order the signal transmission device 133 to send digitalsignals for the control of the constriction/stimulation unit. The signaltransmission device 133 starts a command by generating a high frequencysignal. After a short time, when the signal has energized the implantedparts of the control system, commands are sent to operate theconstriction device of the constriction/stimulation unit 110 inpredefined steps. The commands are sent as digital packets in the formillustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new constriction or release stepis desired the Count byte is increased by one to allow the implantedcontrol unit 135 to decode and understand that another step is demandedby the signal transmission device 133. If any part of the digital packetis erroneous, its content is simply ignored.

Through a line 136, an implanted energizer unit 137 draws energy fromthe high frequency electromagnetic wave signals received by thesignal-receiving device 134. The energizer unit 137 stores the energy ina source of energy, such as a large capacitor, powers the control unit135 and powers the constriction/stimulation unit 110 via a line 138.

The control unit 135 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the signaltransmission device 133. The microprocessor receives the digital packet,decodes it and sends a control signal via a signal line 139 to controlthe constriction device of the constriction/stimulation unit 110 toeither constrict or release the wall portion of the patient's intestinesdepending on the received command code.

FIG. 52 shows a circuitry of an embodiment of the invention, in whichwireless energy is transformed into a current. External components ofthe circuitry include a microprocessor 140, a signal generator 141 and apower amplifier 142 connected thereto. The microprocessor 140 is adaptedto switch the signal generator 141 on/off and to modulate signalsgenerated by the signal generator 141 with digital commands. The poweramplifier 142 amplifies the signals and sends them to an externalsignal-transmitting antenna 143. The antenna 143 is connected inparallel with a capacitor 144 to form a resonant circuit tuned to thefrequency generated by the signal generator 141.

Implanted components of the circuitry include a signal receiving antennacoil 145 and a capacitor 146 forming together a resonant circuit that istuned to the same frequency as the transmitting antenna 143. The signalreceiving antenna coil 145 induces a current from the received highfrequency electromagnetic waves and a rectifying diode 147 rectifies theinduced current, which charges a storage capacitor 148. The storagecapacitor 148 powers a motor 149 for driving the constriction device ofthe constriction/stimulation unit 110. A coil 150 connected between theantenna coil 145 and the diode 147 prevents the capacitor 148 and thediode 147 from loading the circuit of the signal-receiving antenna 145at higher frequencies. Thus, the coil 150 makes it possible to chargethe capacitor 148 and to transmit digital information using amplitudemodulation.

A capacitor 151 and a resistor 152 connected in parallel and a diode 153forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 154 connected in series with aresistor 155 connected in series with a capacitor 156 connected inseries with the resistor 154 via ground, and a capacitor 157, oneterminal of which is connected between the resistors 154,155 and theother terminal of which is connected between the diode 153 and thecircuit formed by the capacitor 151 and resistor 152. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 158 thatdecodes the digital information and controls the motor 149 via anH-bridge 159 comprising transistors 160,161,162 and 163. The motor 149can be driven in two opposite directions by the H-bridge 159.

The microprocessor 158 also monitors the amount of stored energy in thestorage capacitor 148. Before sending signals to activate the motor 149,the microprocessor 158 checks whether the energy stored in the storagecapacitor 148 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 158 waits for the receivedsignals to charge the storage capacitor 148 before activating the motor149.

Alternatively, the energy stored in the storage capacitor 148 may onlybe used for powering a switch, and the energy for powering the motor 149may be obtained from another implanted energy source of relatively highcapacity, for example a battery. In this case the switch is adapted toconnect the battery to the motor 149 in an on mode when the switch ispowered by the storage capacitor 148 and to keep the batterydisconnected from the motor 149 in a standby mode when the switch is notpowered.

FIGS. 53A-53C show an apparatus used for practicing the method of theinvention which is similar to the apparatus of FIG. 2, except that theconstriction/stimulation unit, here denoted by reference numeral 200, isprovided with additional clamping elements. The apparatus of FIGS.53A-53C is suited for actively moving the intestinal contents in theintestinal passageway of a patient's intestines. Thus, theconstriction/stimulation unit 200 also includes a first pair of shortclamping elements 201 and 202, and a second pair of short clampingelements 203 and 204, wherein the first and second pairs of clampingelements are positioned at mutual sides of the elongate clampingelements 5,6. The two short clamping elements 201, 202 of the first pairare radially movable towards and away from each other between retractedpositions (FIG. 53A) and clamping positions (FIGS. 53B and 53C), and thetwo short clamping elements 203, 204 of the second pair are radiallymovable towards and away from each other between retracted positions(FIG. 53C) and clamping positions (FIGS. 53A and 53B). The stimulationdevice 3 also includes electrical elements 7 positioned on the shortclamping elements 201-204, so that the electrical elements 7 on one ofthe short clamping elements 201 and 203, respectively, of each pair ofshort elements face the electrical elements 7 on the other shortclamping element 202 and 204, respectively, of each pair of shortelements.

The constriction/stimulation unit 200 is applied on a wall portion 8 ofa tubular tissue wall of a patient's intestines, so that the shortclamping elements 201, 202 are positioned at an upstream end of the wallportion 8, whereas the short clamping elements 203, 204 202 arepositioned at a downstream end of the wall portion 8. In FIGS. 53A to53C the upstream end of the wall portion 8 is to the left and thedownstream end of the wall portion 8 is to the right.

The control device 4 controls the pair of short clamping elements 201,202, the pair of elongate clamping elements 5, 6 and the pair of shortelements 203, 204 to constrict and release the wall portion 8independently of one another. The control device also controls theelectrical elements 7 on a clamping element that is constricting thewall portion to stimulate the constricted wall portion 8 with electricpulses to cause contraction of the wall portion 8, so that theintestinal passageway of the wall portion 8 is closed.

FIGS. 53A-53C illustrate how the control device 4 controls the operationof the constriction/stimulation unit 200 to cyclically move intestinalcontents downstream in the intestinal passageway of the wall portion 8.Thus, in FIG. 53A the short clamping elements 201, 202 and the elongateclamping elements 5, 6 are in their retracted positions, whereas theshort clamping elements 203, 204 are in their clamping positions whilethe electrical elements 7 on elements 203, 204 electrically stimulatethe wall portion 8. The electrical stimulation causes the wall portion 8at the elements 203, 204 to thicken, whereby the intestinal passagewayis closed. FIG. 53B illustrates how also the short clamping elements201, 202 have been moved radially inwardly to their clamping positionswhile the electrical elements 7 on elements 201, 202 electricallystimulate the wall portion 8, whereby a volume of bodily matter istrapped in the intestinal passageway between the upstream and downstreamends of the wall portion 8. FIG. 53C illustrates how initially the shortclamping elements 203, 204 have been moved radially outwardly to theirretracted positions, and then the elongate clamping elements 5, 6 havebeen moved radially inwardly to their clamping positions while theelectrical elements 7 on elements 5, 6 electrically stimulate the wallportion 8. As a result, the bodily matter in the intestinal passagewaybetween the upstream and downstream ends of the wall portion 8 has beenmoved downstream in the intestinal passageway as indicated by an arrow.Then, the control device 4 controls the constriction/stimulation unit200 to assume the state shown in FIG. 53A, whereby bodily matter mayflow into and fill the intestinal passageway between the upstream anddownstream ends of the wall portion 8, so that the cycle of theoperation is completed.

Alternatively, the operation cycle of the constriction/stimulation unit200 described above may be reversed, in order to move bodily matterupstream in the intestinal passageway. In this case the control device 4controls the short clamping elements 203, 204 to constrict the wallportion 8 at the downstream end thereof to restrict the flow in theintestinal passageway and controls the electric elements 7 to stimulatethe constricted wall portion 8 with electric pulses at the downstreamend to close the intestinal passageway. With the intestinal passagewayclosed at the downstream end of the constricted wall portion 8 and theshort clamping elements 201, 202 in their retracted positions, as shownin FIG. 53A, the control device 4 controls the elongate clampingelements 5, 6 to constrict the wall portion 8 between the upstream anddownstream ends thereof. As a result, the intestinal contents containedin the wall portion 8 between the upstream and downstream ends thereofis moved upstream in the intestinal passageway.

Although FIGS. 53A-53C disclose pairs of clamping elements, it should benoted that it is conceivable to design the constriction/stimulation unit200 with only a single short clamping element 201, a single elongateclamping element 5 and a single short clamping element 203. In this casethe bottom of the tubular wall portion 8 is supported by stationaryelements of the constriction/stimulation unit 200 opposite to theclamping elements 201, 5, 203.

FIGS. 54A and 54B schematically show another apparatus used forpracticing the method of the invention, in particular for activelymoving the intestinal contents in the intestinal passageway of apatient's tubular intestines. The apparatus of FIGS. 54A and 54Bincludes a constriction/stimulation unit 205, the constriction device206 of which has a rotor 207, which carries three cylindricalconstriction elements 208A, 208B and 208C positioned equidistantly fromthe axis 209 of the rotor 207. The constriction elements 208A-208C maybe designed as rollers. Each cylindrical element 208A-208C is providedwith electrical elements 7. A stationary elongate support element 210 ispositioned spaced from but close to the rotor 207 and has a partcylindrical surface 211 concentric with the axis 209 of the rotor 207.The constriction/stimulation unit 205 is applied on a patient's tubularintestines 212, so that the intestines 212 extends between the supportelement 210 and the rotor 207.

The control device 4 controls the rotor 207 of the constriction deviceto rotate so that the constriction elements 208A-208C successivelyconstrict wall portions of a series of wall portions of the tubularintestines 212 against the elongate support element 210. The electricalelements 7 of the constriction elements 208A-208C stimulate theconstricted wall portions with electric pulses so that the wall portionsthicken and close the intestinal passageway of the intestines 212. FIG.54A illustrates how the constriction element 208A has started toconstrict the wall of the intestines 212 and how the intestinalpassageway of the intestines 212 is closed with the aid of theelectrical elements 7 on the constriction element 208A, whereas theconstriction element 208B is about to release the intestines 212. FIG.54B illustrates how the constriction element 208A has advanced abouthalfway along the elongate support element 210 and moved the bodilymatter in the intestinal passageway in a direction indicated by anarrow. The constriction element 208B has released the intestines 212,whereas the constriction element 208C is about to engage the intestines212. Thus, the control device 4 controls the rotor 207 to cyclicallymove the constriction elements 208A-208C one after the other along theelongate support element 210 while constricting the wall portions of theintestines 212, so that the bodily matter in the intestines 212 is movedin a peristaltic manner.

FIGS. 55A, 55B and 55C show another mechanically operable constrictiondevice 213 used for practicing the method of the invention. Referring toFIG. 55A, the constriction device 213 includes a first ring-shapedholder 214 applied on a tubular intestines 8 of a patient and a secondring-shaped holder 215 also applied on the intestines 8 spaced apartfrom holder 214. There are elastic strings 216 (here twelve strings)that extend in parallel along the tubular intestines 8 and interconnectthe two holders 213, 214 without contacting the intestines 8. FIG. 55Aillustrate an inactivated state of the constriction device 213 in whichthe intestines 8 is not constricted.

Referring to FIGS. 55B and 55C, when intestines 8 is to be constrictedthe ring-shaped holders 213 and 214 are rotated by an operation means(not shown) in opposite directions, whereby the elastic strings 216constrict the intestines 8 in a manner that appears from FIGS. 55B and55C. For the sake of clarity, only five strings 216 are shown in FIG.55B.

In accordance with the present invention, electrodes for electricallystimulating the intestines 8 to cause contraction of the wall of theintestines 8 are attached to the strings 216 (not shown in FIGS.55A-55C).

FIG. 56 schematically illustrates an arrangement capable of sendinginformation from inside the patient's body to the outside thereof togive information related to at least one functional parameter of theapparatus, and/or related to a physical parameter of the patient, inorder to supply an accurate amount of energy to an implanted internalenergy receiver 302 connected to energy consuming components of animplanted constriction/stimulation unit 301 of the apparatus. Such anenergy receiver 302 may include a source of energy and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external source of energy 304 a located outside thepatient and is received by the internal energy receiver 302 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the constriction/stimulation unit 301 via a switch 326. An energybalance is determined between the energy received by the internal energyreceiver 302 and the energy used for the constriction/stimulation unit301, and the transmission of wireless energy is then controlled based onthe determined energy balance. The energy balance thus provides anaccurate indication of the correct amount of energy needed, which issufficient to operate the constriction/stimulation unit 301 properly,but without causing undue temperature rise.

In FIG. 56 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external source of energy 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal source of energy 304 a and an adjacent secondary coil arrangedin the implanted energy-transforming device 302. When an electriccurrent is fed through the primary coil, energy in the form of a voltageis induced in the secondary coil which can be used to power theimplanted energy consuming components, e.g. after storing the incomingenergy in an implanted source of energy, such as a rechargeable batteryor a capacitor. However, the present invention is generally not limitedto any particular energy transfer technique, TET devices or energysources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalsource of energy 304 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 315 connected between the switch 326 andthe constriction/stimulation unit 301. The internal control unit 315 maythus be arranged to receive various measurements obtained by suitablesensors or the like, not shown, measuring certain characteristics of theconstriction/stimulation unit 301, somehow reflecting the requiredamount of energy needed for proper operation of theconstriction/stimulation unit 301. Moreover, the current condition ofthe patient may also be detected by means of suitable measuring devicesor sensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the constriction/stimulation unit 301, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by parametyers such as: body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere.

Furthermore, a source of energy in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the constriction/stimulation unit 301. Alternatively or additionally,characteristics of such an accumulator, also reflecting the requiredamount of energy, may be measured as well. The accumulator may bereplaced by a rechargeable battery, and the measured characteristics maybe related to the current state of the battery, any electrical parametersuch as energy consumption voltage, temperature, etc. In order toprovide sufficient voltage and current to the constriction/stimulationunit 301, and also to avoid excessive heating, it is clearly understoodthat the battery should be charged optimally by receiving a correctamount of energy from the implanted energy-transforming device 302, i.e.not too little or too much. The accumulator may also be a capacitor withcorresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus, or the patient, or an implanted source ofenergy if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal source of energy 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 56employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components. The apparatus may use the received energyeither for consuming or for storing the energy in an implanted source ofenergy or the like. The different parameters discussed above would thusbe used if relevant and needed and then as a tool for determining theactual energy balance. However, such parameters may also be needed perse for any actions taken internally to specifically operate theapparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external source of energy 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. Such an integrated information feedbackand energy system comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises a powerswitch for switching the connection of the internal first coil to thefirst electronic circuit on and off, such that feedback informationrelated to the charging of the first coil is received by the externalenergy transmitter in the form of an impedance variation in the load ofthe external second coil, when the power switch switches the connectionof the internal first coil to the first electronic circuit on and off.In implementing this system in the arrangement of FIG. 17, the switch326 is either separate and controlled by the internal control unit 315,or integrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 56 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external source of energy 304 a can then be regulatedby the external control unit 304 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external source of energy 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics. This system may also be used to obtain informationabout the coupling factors between the coils in a TET system even tocalibrate the system both to find an optimal place for the external coilin relation to the internal coil and to optimize energy transfer. Simplycomparing in this case the amount of energy transferred with the amountof energy received. For example if the external coil is moved thecoupling factor may vary and correctly displayed movements could causethe external coil to find the optimal place for energy transfer.Preferably, the external coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 57, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 57,wherein an external switch 326 is interconnected between the externalsource of energy 304 a and an operation device, such as an electricmotor 307 operating the constriction/stimulation unit 301. An externalcontrol unit 304 b controls the operation of the external switch 326 toeffect proper operation of the constriction/stimulation unit 301.

FIG. 58 illustrates different embodiments for how received energy can besupplied to and used by the constriction/stimulation unit 301. Similarto the example of FIG. 56, an internal energy receiver 302 receiveswireless energy E from an external source of energy 304 a which iscontrolled by a transmission control unit 304 b. The internal energyreceiver 302 may comprise a constant voltage circuit, indicated as adashed box “constant V” in FIG. 58, for supplying energy at constantvoltage to the constriction/stimulation unit 301. The internal energyreceiver 302 may further comprise a constant current circuit, indicatedas a dashed box “constant C” in the figure, for supplying energy atconstant current to the constriction/stimulation unit 301.

The constriction/stimulation unit 301 comprises an energy consuming part301 a, which may be a motor, pump, restriction device, or any othermedical appliance that requires energy for its electrical operation. Theconstriction/stimulation unit 301 may further comprise an energy storagedevice 301 b for storing energy supplied from the internal energyreceiver 302. Thus, the supplied energy may be directly consumed by theenergy consuming part 301 a, or stored by the energy storage device 301b, or the supplied energy may be partly consumed and partly stored. Theconstriction/stimulation unit 301 may further comprise an energystabilizing unit 301 c for stabilizing the energy supplied from theinternal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the constriction/stimulation unit 301, before beingconsumed and/or stored by the constriction/stimulation unit 301.Alternatively, the energy stabilizing unit 328 may be integrated in theinternal energy receiver 302. In either case, the energy stabilizingunit 328 may comprise a constant voltage circuit and/or a constantcurrent circuit.

It should be noted that FIG. 56 and FIG. 58 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 59 schematically shows an energy balance measuring circuit of oneof the proposed designs of the apparatus for controlling transmission ofwireless energy, or energy balance. The circuit has an output signalcentered on 2.5V and proportionally related to the energy imbalance. Thederivative of this signal shows if the value goes up and down and howfast such a change takes place. If the amount of received energy islower than the energy used by implanted components of the apparatus,more energy is transferred and thus charged into the source of energy.The output signal from the circuit is typically fed to an A/D converterand converted into a digital format. The digital information can then besent to the external energy-transmission device allowing it to adjustthe level of the transmitted energy. Another possibility is to have acompletely analog system that uses comparators comparing the energybalance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 59 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatusfrom outside of the patient's body using inductive energy transfer. Aninductive energy transfer system typically uses an external transmittingcoil and an internal receiving coil. The receiving coil, L1, is includedin the schematic FIG. 59; the transmitting parts of the system areexcluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 59 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

The embodiments described in connection with FIGS. 56, 58 and 59identify a general method of the present invention for controllingtransmission of wireless energy to implanted energy consuming componentsof the apparatus. Such a method will be defined in general terms in thefollowing.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal source of energy located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the implanted energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto. An energy balance is determined between theenergy received by the internal energy receiver and the energy used forthe operation of the implanted parts of the apparatus. The transmissionof wireless energy E from the external source of energy is thencontrolled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external source of energy to a secondary coil in the internalenergy receiver. A change in the energy balance may be detected tocontrol the transmission of wireless energy based on the detected energybalance change. A difference may also be detected between energyreceived by the internal energy receiver and energy used for theoperation of the implanted parts of the apparatus, to control thetransmission of wireless energy based on the detected energy difference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the operation of the implantedparts of the apparatus be consumed to operate the implanted parts of theapparatus and/or stored in at least one implanted energy storage deviceof the apparatus.

When electrical and/or physical parameters of the implanted parts of theapparatus and/or physical parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external source of energymay be controlled by applying to the external source of energyelectrical pulses from a first electric circuit to transmit the wirelessenergy, the electrical pulses having leading and trailing edges, varyingthe lengths of first time intervals between successive leading andtrailing edges of the electrical pulses and/or the lengths of secondtime intervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external sourceof energy may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A constriction device can be arranged to delay the movement of the fecalmatter in a lumen of the intestine for a predetermined amount of time.This can be achieved in many different ways, of which two will bedescribed below.

FIG. 60 is a sectional view through a constriction device 2 adapted torestrict or stop the flow through an n intestine. The general flowdirection is illustrated by an arrow. The constriction device comprisesan array of constriction elements 2 a-2 m, each arranged to restrict orclose a part of the intestine. The constriction device illustrated inFIG. 56 is in an open or non-operative position wherein the flow isuninterrupted.

FIG. 61A illustrates the constriction device of FIG. 60 in a firstinterrupting stage, wherein every other constriction element is in aclosed position. A fecal matter, generally designated 1000, is allowedto enter the space formed by the first, non-closed constriction element.It is stopped there by the second constriction element, which is in aclosed position. This operative state can remain for a desired period oftime, such as one day.

FIG. 61B illustrates the constriction device of FIG. 60 in a secondinterrupting stage, wherein every constriction element that was closedin the first interrupting stage is in an open position and vice versa.The fecal matter is then allowed to enter the space formed by thesecond, non-closed constriction element. It is stopped there by thethird constriction element, which is in a closed position. Thisoperative state can remain for a desired period of time, such as oneday.

FIG. 61A illustrates the constriction device of FIG. 60 in a thirdinterrupting stage, wherein every other constriction element is in aclosed position, exactly as in the first interrupting stage. The fecalmatter shown in FIGS. 61A and 61B, is allowed to enter the space formedby the third, non-closed constriction element. It is stopped there bythe fourth constriction element, which is in a closed position. Thisoperative state can remain for a desired period of time, such as oneday.

Repeating this process, the movement of a fecal matter can be delayedfor a desired period of time until it reaches the other end of theconstriction device. By altering the constricted area of the intestine,this will not be harmed like if the same area were constricted for alonger period of time.

FIGS. 62A-D show a second embodiment of a constriction device. Thisoperates in a way similar to the first embodiment of a constrictiondevice shown in FIGS. 61A-C. However, in this embodiment, twoconsecutive constriction elements are in an open position at a time whenallowing progress of the fecal matter.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

I claim:
 1. An intestinal dysfunction treatment apparatus comprising: animplantable constriction device configured to gently constrict a portionof a tissue wall of a patient's intestines to restrict a flow ofintestinal contents in an intestinal passageway of the intestines, astimulation device configured to stimulate the portion, a sensorconfigured to measure a temperature of the intestinal dysfunctiontreatment apparatus, and a control device configured to be operable tocontrol; the stimulation device to stimulate the portion, as theconstriction device constricts the portion, to cause contraction of theportion to further restrict the flow of intestinal contents, theconstriction device to adjust the constriction of the portion, and theconstriction and stimulation devices independently of each other.
 2. Theapparatus according to claim 1, wherein the constriction device isadapted to constrict the portion to a constricted state in which bloodcirculation in the constricted portion is substantially unrestricted andthe flow in the intestinal passageway is at least restricted, and thecontrol device controls the stimulation device to cause contraction ofthe portion, so that the flow in the intestinal passageway is at leastfurther restricted when the portion is kept by the constriction devicein the constricted state, and wherein the control device is configuredto control the stimulation device to intermittently and individuallyelectrically stimulate different areas of the portion in the constrictedstate with electric pulses.
 3. The apparatus according to claim 1,wherein the control device is configured to: control the constrictiondevice to adjust the constriction of the portion, control thestimulation device to stimulate or not to stimulate the portion, whilethe control device controls the constriction device to adjust theconstriction of the portion, and calibrate the constriction device bycontrolling the stimulation device to stimulate the wad-portion whilecontrolling the constriction device to adjust the constriction of theportion until a desired restriction of the flow in the intestinalpassageway is obtained.
 4. The apparatus according to claim 1, whereinthe control device is configured to: control the constriction device toadjust the constriction of the portion, such that the flow in theintestinal passageway is restricted but not stopped, and control thestimulation device to stimulate the constricted portion to causecontraction thereof, such that the flow in the intestinal passageway isfurther restricted but not stopped, or control the stimulation device ina first mode to stimulate the constricted portion to stop the flow inthe intestinal passageway and control the stimulation device in a secondmode to cease stimulating the portion to allow flow in the intestinalpassageway.
 5. The apparatus according to claim 1, wherein the controldevice is configured to: control the constriction device to adjust theconstriction of the portion, such that the flow in the intestinalpassageway is substantially stopped, and is configured to: control thestimulation device to stimulate the constricted portion to causecontraction thereof, such that the flow in the intestinal passageway iscompletely stopped, control the stimulation device in a first mode tostimulate the constricted portion to completely stop the flow in theintestinal passageway, and control the stimulation device in a secondmode to cease the stimulation of the portion to allow flow in theintestinal passageway, or control in the second mode the stimulationdevice to cease stimulating the portion and the constriction device torelease the portion to restore the flow in the intestinal passageway. 6.The apparatus according to claim 1, wherein the control device isconfigured to control the constriction device in a first mode toconstrict the constricted portion to stop the flow in the intestinalpassageway and to control the constriction device in a second mode tocease the constriction of the portion to restore the flow in theintestinal passageway.
 7. The apparatus according to of claim 1, whereinthe control device comprises a manually operable switch for switching onand off the constriction device and/or stimulation device, the switchbeing adapted for subcutaneous implantation in the patient to allow theswitch to be manually operated from outside the patient's body.
 8. Theapparatus according to claim 1, wherein the constriction device isconfigured to normally keep the patient's portion in a constrictedstate, in which blood circulation in the constricted portion issubstantially unrestricted and the flow in the intestinal passageway isat least restricted, wherein the control device is configured to controlthe stimulation device in a first mode to stimulate the constrictedportion to cause contraction thereof to further restrict but not stopthe flow in the intestinal passageway, or configured to stimulate theconstricted portion to cause contraction thereof, such that the flow inthe intestinal passageway is stopped, and wherein the control devicecontrols the stimulation device in a second mode to cease stimulatingthe portion to increase the flow in the intestinal passageway.
 9. Theapparatus according to claim 1, wherein the control device is configuredto control the stimulation device to adjust an intensity of astimulation of the portion in response to a sensed physical parameter ofthe patient or a functional parameter of the apparatus.
 10. Theapparatus according to claim 1, wherein the control device is configuredto control the stimulation device to stimulate the constricted portionto cause contraction thereof, such that the flow in the intestinalpassageway is stopped, and wherein the control device is configured tocontrol the stimulation device to increase an intensity of a stimulationin response to a sensed parameter related to an increase of pressure inthe intestinal passageway, such that the flow in the intestinalpassageway remains stopped, and wherein the apparatus further comprisesa sensor configured to sense a physical parameter of the patient thatrelates to the pressure in the intestinal passageway, wherein thecontrol device is configured to control the stimulation device inresponse to signals from the sensor, wherein the physical parameter isrelated to a pressure in the patient's body and the sensor is a pressurerelated sensor.
 11. The apparatus according to claim 1, wherein thecontrol device is configured to control the stimulation device tointermittently and individually stimulate different areas of theportion, such that at least two of the different areas are stimulated atdifferent points of time, and wherein the control device is configuredto control the stimulation device to intermittently stimulate each areaof the different areas of the portion during successive time periods,each time period being short enough to maintain over time satisfactoryblood circulation in the area during each time period, or the areas ofthe portion, such that an area of the portion that currently is notstimulated has time to restore substantially normal blood circulationbefore the stimulation device stimulates the area again.
 12. Theapparatus according to claim 1, wherein the control device is configuredto control the stimulation device to stimulate different areas of theportion at a time by sequentially stimulating the different areas of theportion, or by shifting over time a stimulation from one area to anothersuch that both areas are temporarily stimulated at the same time duringa stimulation shift.
 13. The apparatus according to claim 1, wherein thecontrol device is configured to control the stimulation device tointermittently and individually electrically stimulate different areasof the portion with electric pulses, and wherein the stimulation devicecomprises at least one electrical element for engaging the portion andfor stimulating the portion with electric pulses.
 14. The apparatusaccording to claim 13, wherein the pulses form pulse trains, and whereinthe control device is configured to control the stimulation device tovary at least one of the following pulse parameters: off time periodsbetween individual pulses of each pulse train, off time periods betweenthe pulse trains, width of each pulse of the pulse trains, length ofeach pulse train, pulse amplitudes of the pulses of the pulse trains,frequency of the pulses of the pulse trains, frequency of the pulsetrains, and number of pulses of each pulse train, wherein at least afirst area and a second area of the areas of the portion are repeatedlystimulated with a first pulse train of the pulse trains and a secondpulse train of the pulse trains, respectively, such that the first andsecond pulse trains over time are shifted relative to each other, andwherein the first area is stimulated with the first pulse train whilethe second area is not stimulated with the second pulse train, and viceversa, or the first and second pulse trains are shifted relative to eachother such that the first and second pulse trains at least partiallyoverlap each other.
 15. The apparatus according to claim 13, wherein theportion includes muscle fibers and the stimulation device is configuredto stimulate the portion including the muscle fibers with the electricpulses, to cause contraction of the muscle fibers to contract theportion.
 16. The apparatus according to claim 13, wherein thestimulation device comprises electrical elements and a structure holdingthe electrical elements in a fixed orientation, the structure beingintegrated in or separate from the constriction device, and wherein theelectrical elements form an elongate pattern of electrical elements andthe structure is applicable on the patient's intestines such that theelongate pattern of electrical elements extends along the portion of theintestines in the direction of the flow in the intestinal passageway andthe elements abut a respective area of the portion.
 17. The apparatusaccording to claim 13, wherein the stimulation device compriseselectrical elements and the control device is configured to control thestimulation device to electrically energize the electrical elements, andto control the stimulation device to energize the electrical elements,such that a number or groups of the electrical elements are energized atthe same time or such that the electrical elements are energized one ata time in sequence or groups of the electrical elements are sequentiallyenergized, either randomly or in accordance with a predeterminedpattern.
 18. The apparatus according to claim 13, wherein thestimulation device comprises electrical elements and the electricalelements form an elongate pattern of electrical elements, wherein theelements are applicable on the patient's wall such that the elongatepattern of electrical elements extends along the portion of theintestines in the direction of the flow in the intestinal passageway andthe elements abut a respective area of the portion, and wherein thecontrol device is configured to control the stimulation device tosuccessively energize the electrical elements longitudinally along theelongate pattern of electrical elements, or to successively energize theelectrical elements along the elongate pattern of electrical elements ina direction opposite to, or in the same direction as, that of the flowin the intestinal passageway, when the stimulation device is applied onthe patient's intestines, or to successively energize the electricalelements from a position substantially at a center of the constrictedportion towards a respective end of the elongate pattern of electricalelements, when the stimulation device is applied on the patient'sintestines.
 19. The apparatus according to claim 13, wherein thestimulation device comprises electrical elements and the control deviceis configured to control the stimulation device to energize theelectrical elements, such that electrical elements currently energizedform a group of adjacent energized electrical elements, wherein theelements in the group of energized electrical elements form a path ofenergized electrical elements, and wherein the path of energizedelectrical elements extends along the patient's intestines, or at leastin part or completely around the patient's intestines, when thestimulation device is applied on the intestines.
 20. The apparatusaccording to claim 13, wherein the stimulation device compriseselectrical elements and the electrical elements form groups of elements,the groups forming a series of groups extending along the patient'sintestines in the direction of flow in the patient's intestinalpassageway, when the stimulation device is applied on the intestines,the electrical elements of each group of electrical elements forming apath of elements extending along the patient's intestines, or at leastin part or completely around the patient's intestines, and wherein thecontrol device is configured to control the stimulation device tosuccessively energize the groups of electrical elements in the series ofgroups in a direction opposite to, or in a same direction as, that ofthe flow in the intestinal passageway, when the stimulation device isapplied on the patient's intestines, or to successively energize thegroups of electrical elements in the series of groups from a positionsubstantially at the center of the constricted portion in a directionopposite to and in the same direction as that of the flow in theintestinal passageway, when the stimulation device is applied on thepatient's intestines.
 21. The apparatus according to claim 1, whereinthe stimulation device is configured to thermally stimulate the portion,either by cooling the constricted portion to cause contraction of theportion or by heating the portion, when the portion is constricted andcontracted, to cause expansion of the portion, and wherein theconstriction device is adapted to constrict the portion to at leastrestrict the flow in the intestinal passageway, and the control deviceis configured to control the stimulation device to cool the constrictedportion to cause contraction thereof, such that the flow in theintestinal passageway is at least further restricted but not stopped, orfurther restricted and stopped.
 22. The apparatus according to claim 1,wherein the constriction device is configured to constrict the portionmechanically or hydraulically, and/or the stimulation device isconfigured to stimulate the portion with electric pulses or thermally.